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Cochlear Implantation in Cases of Single-Sided Deafness (CI in SSD)

Primary Purpose

Unilateral Moderate to Profound Hearing Loss, Asymmetric Hearing Loss, Single-Sided Deafness (SSD)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cochlear Implant

Control Group

About this trial

This is an interventional treatment trial for Unilateral Moderate to Profound Hearing Loss focused on measuring Unilateral hearing loss, Single Sided Deafness, Asymmetric hearing loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (SSD):

Unilateral moderate-to-profound sensorineural hearing loss [Unaided residual hearing thresholds measured from 250-8000 Hertz (Hz) (Pure Tone Average (PTA) ≥70 decibel (dB) Hearing Level (HL) in the ear to be implanted]
Normal to mild residual hearing thresholds from 250-8000 Hz in the contralateral ear (≤35 dB HL at each frequency, 250-8000 Hz)
Greater than or equal to 18 years of age at implantation
Duration of moderate-to-profound sensorineural hearing loss less than or equal to 5 years [Either reported by subject or documented in previous audiograms] [Can be less than or equal to 10 years if the subject consistently utilized hearing technology (such as a bone conduction device or conventional hearing aid) within the past 5 years]
Previous experience with a current treatment option for SSD, including a conventional hearing aid, bone-conduction device, or CROS/BICROS (Bilateral Contralateral Routing Of the Signal) technology. [At least one month of listening experience with device] [Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit]
Aided word recognition in the ear to be implanted of 60% or less as measured with Consonant-Nucleus-Consonant (CNC) words (50-word list) [When listening with an appropriately fit hearing aid and masking applied to the contralateral ear] [Aided testing will be conducted in a sound-proof booth with the subject seated 1 meter from the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB Sound Pressure Level (SPL).] [The hearing aid output will be measured using National Acoustic Laboratory-NonLinear (NAL-NL1) targets.]
Realistic expectations
Willing to obtain recommended meningitis vaccinations per Center for Disease Control (CDC) recommendations
No reported cognitive issues [Pass the Mini Mental State Examination (MMSE) screener]
Able and willing to comply with study requirements, including travel to investigational site and study-related activities

Exclusion Criteria (SSD):

Non-native English speaker [Speech perception materials are presented in English]
Conductive hearing loss in either ear
Compromised auditory nerve, including those with a history of vestibular schwannoma
Ossification
Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
History of meningitis, autoimmune disease, or any medical condition that contraindicate middle or inner ear surgery or anesthesia
Meniere's disease with intractable vertigo
Trauma that precludes inner ear surgery
Case of sudden sensorineural hearing loss that has not been first evaluated by a physician
Pregnancy [Subjects who are pregnant or become pregnant prior to surgery are excluded due to the potential risk of anesthesia to an unborn child.] [Subjects who become pregnant after surgery may continue to participate in study procedures]
Tinnitus as the primary purpose for seeking cochlear implantation
Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory (Newman, Jacobson & Spitzer, 1996).

Inclusion Criteria (asymmetric hearing loss):

a. Ear to be implanted i. Moderate-to-profound sensorineural hearing loss ii. PTA ≥70 dB HL iii. Aided word recognition of 60% or less as measured with CNC words (50-word list).

b. Contralateral ear i. PTA ≥35 and ≤55 dB HL ii. Aided word recognition of 80% or more as measured with CNC words (50-word list).

iii. Use of conventional amplification c. Greater than or equal to 18 years of age at implantation d. Duration of moderate-to-profound sensorineural hearing loss in the ear to be implanted is less than or equal to 5 years [Either reported by subject or documented in previous audiograms. Can be up to 10 years if the subject consistently utilized hearing technology in the ear to be implanted (such as a bone conduction device or conventional hearing aid) within the past 5 years] e. Previous experience with a current treatment option for asymmetric hearing loss, including a conventional hearing aid, bone-conduction device, or CROS/BiCROS technology. [At least one month of listening experience with device. Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit.] f. Realistic expectations g. Willing to obtain recommended meningitis vaccinations per CDC recommendations h. No reported cognitive issues [Pass the Mini Mental State Examination (MMSE) screener] i. Able and willing to comply with study requirements, including travel to investigational site and study-related activities

Exclusion Criteria (Asymmetric hearing loss):

Non-English speaker [Speech perception materials are presented in English]
Medical condition considered a contraindication to undergoing cochlear implantation
Conductive hearing loss in either ear
Compromised auditory nerve, including those with a history of vestibular schwannoma
Ossification
Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
History of meningitis, autoimmune disease, or any medical condition that contraindicate middle or inner ear surgery or anesthesia
Meniere's disease with intractable vertigo
Trauma that precludes inner ear surgery
Case of sudden sensorineural hearing loss that has not been first evaluated by a physician
Pregnancy [Subjects who are pregnant or become pregnant prior to surgery are excluded due to the potential risk of anesthesia to an unborn child. Subjects who become pregnant after surgery may continue to participate in study procedures]
Tinnitus as the primary purpose for seeking cochlear implantation
Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory (Newman, Jacobson & Spitzer, 1996).

Sites / Locations

University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

Cochlear Implant

Control Group

Cochlear Implant: Asymmetric hearing loss

Arm Description

Cochlear implantation of the affected ear

A control group without the study intervention (cochlear implantation) will complete the test battery.

Cochlear implantation of the poorer hearing ear

Outcomes

Primary Outcome Measures

Change in Word Recognition in Quiet Over Time

Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use.

Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time

Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.

Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated.

Change in Localization Results (Measured in Variable Error) Over Time

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Change in Localization Results (Measured in Constant Error) Over Time

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Change in Localization Results (Measured in Adjusted Constant Error) Over Time

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time

Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.

Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time

Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.

Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated.

Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated.

Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR).

Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR).

Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR).

Secondary Outcome Measures

Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)

Results on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores <20%).

Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance.

Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)

Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)

Subjects completed subjective questionnaires. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.

Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)

Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)

Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)

Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)

The speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off.

Speech Recognition in Noise for a Control Group: BKB-SIN Test

The speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off.

Localization for a Control Group

Subjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off.

Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)

Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.

Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)

Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.

Full Information

NCT ID

NCT02203305

First Posted

July 22, 2014

Last Updated

July 20, 2022

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Med-El Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02203305

Brief Title

Cochlear Implantation in Cases of Single-Sided Deafness

Acronym

CI in SSD

Official Title

Cochlear Implantation in Cases of Single-Sided Deafness

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

October 2014 (Actual)

Primary Completion Date

September 16, 2021 (Actual)

Study Completion Date

September 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Med-El Corporation

4. Oversight

5. Study Description

Brief Summary

The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.

Detailed Description

Single-sided deafness (SSD) can be defined as moderate-to-profound sensorineural hearing loss with limited speech perception benefit in one ear and normal hearing in the contralateral ear. Though one ear is within the normal hearing limits, SSD may result in reduced speech perception in noise, variable abilities on localization tasks, increased subjective report of hearing handicap, and reduced quality of life. This patient population cannot utilize conventional amplification due to the severity of the hearing loss and poor speech discrimination abilities in the affected ear. Current treatment options include: contralateral routing of the signal (CROS) hearing aids, and bone-conduction devices. A CROS hearing aid is a two-part system that includes a microphone/transmitter on the affected ear and a receiver on the normal hearing ear. The microphone/transmitter sends the acoustic signal from the affected ear to the receiver, which is presented to the normal hearing ear. Bone-conduction devices utilize a percutaneous, implanted titanium abutment to send the acoustic signal from the affected side to the normal hearing ear via vibrations. The goal of both of these technologies is to send the signal from the affected side to the normal hearing side, thereby leaving the patient in a unilateral listening condition. Though CROS hearing aids and bone-conduction devices provide the patient with auditory information from both sides to the better hearing ear, the ability to use binaural cues for speech perception in noise is variable. It is of interest whether cochlear implantation of the affected ear would benefit the SSD population. A cochlear implant is a two-part system, including the internal electrode array and external speech processor. The internal electrode array is surgically implanted into the affected cochlea. The external speech processor receives sounds and transmits this signal to the internal portion. The electrode array presents the acoustic signal via electrical pulses within the cochlea, which is interpreted by the brain as sound. Presumably, cochlear implantation may provide the SSD population improvements in speech perception in the affected ear, which cannot benefit from appropriately fit hearing aids. Cochlear implantation may provide a benefit over current treatment options in the SSD population, as it stimulates the auditory pathway on the affected side, thus allowing for ipsilateral representation of acoustic signals arriving to each ear independently. The primary goal of this project is to determine whether subjects with SSD experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition. Secondary aims include: 1) a comparison of speech perception, localization, and quality of life outcomes in the study population to a SSD control group with long-term listening experience with a current treatment option (i.e. bone-conduction device), and 2) a within-subject comparison of speech perception and localization abilities with cochlear implantation versus the bone-conduction test device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unilateral Moderate to Profound Hearing Loss, Asymmetric Hearing Loss, Single-Sided Deafness (SSD)

Keywords

Unilateral hearing loss, Single Sided Deafness, Asymmetric hearing loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cochlear Implant

Arm Type

Experimental

Arm Description

Cochlear implantation of the affected ear

Arm Title

Control Group

Arm Type

Other

Arm Description

A control group without the study intervention (cochlear implantation) will complete the test battery.

Arm Title

Cochlear Implant: Asymmetric hearing loss

Arm Type

Experimental

Arm Description

Cochlear implantation of the poorer hearing ear

Intervention Type

Device

Intervention Name(s)

Cochlear Implant

Other Intervention Name(s)

MED-EL CONCERT cochlear implant system, MED-EL SYNCHRONY cochlear implant system

Intervention Description

cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss

Intervention Type

Other

Intervention Name(s)

Control Group

Other Intervention Name(s)

bone-conduction device

Intervention Description

Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.

Primary Outcome Measure Information:

Title

Change in Word Recognition in Quiet Over Time

Description

Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use.

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Localization Results (Measured in Variable Error) Over Time

Description

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Localization Results (Measured in Constant Error) Over Time

Description

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Localization Results (Measured in Adjusted Constant Error) Over Time

Description

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front

Description

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated.

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Secondary Outcome Measure Information:

Title

Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)

Description

Time Frame

preoperative interval and 12 month post-activation interval

Title

Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Description

Time Frame

preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)

Title

Description

Time Frame

Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Title

Description

Time Frame

preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)

Title

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)

Description

Time Frame

preoperative interval and 12 month post-activation interval

Title

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)

Description

Time Frame

preoperative interval and 12 month post-activation interval

Title

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)

Description

Time Frame

preoperative interval and 12 month post-activation interval

Title

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)

Description

Time Frame

preoperative interval and 12 month post-activation interval

Title

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)

Description

Time Frame

preoperative interval and 12 month post-activation interval

Title

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)

Description

Time Frame

preoperative interval and 12 month post-activation interval

Title

Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)

Description

Time Frame

Assessment completed after 12 months of implantable bone-conduction listening experience

Title

Speech Recognition in Noise for a Control Group: BKB-SIN Test

Description

Time Frame

Assessment completed after 12 months of implantable bone-conduction listening experience

Title

Localization for a Control Group

Description

Time Frame

Assessment completed after 12 months of implantable bone-conduction listening experience

Title

Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)

Description

Time Frame

Assessment completed after 12 months of implantable bone-conduction listening experience

Title

Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)

Description

Time Frame

Assessment completed after 12 months of implantable bone-conduction listening experience

Other Pre-specified Outcome Measures:

Title

Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period

Description

Participants completed an adaptive pitch matching task that compared the pitch of acoustic stimulation presented to their normal hearing ear with the perception of stimulation from the cochlear implant. Two stimuli were used: clicks & tones. Pitch perception was evaluated for the 5 most apical electrodes. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / frequency information presented by the electrode. Results are reported as the averaged normalized score for clicks & tones for each electrode (electrodes 1-5) at each interval (1, 3, 6, and 12 months post-activation). A value of 1.0 indicates the participant perceived the same frequency as the center frequency presented by the electrode. A value < 1.0 indicates a lower perceived pitch and a value > 1.0 indicates a higher perceived pitch than the electric frequency information.

Time Frame

post-activation period (1, 3, 6, and 12 months post-activation)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (SSD): Unilateral moderate-to-profound sensorineural hearing loss [Unaided residual hearing thresholds measured from 250-8000 Hertz (Hz) (Pure Tone Average (PTA) ≥70 decibel (dB) Hearing Level (HL) in the ear to be implanted] Normal to mild residual hearing thresholds from 250-8000 Hz in the contralateral ear (≤35 dB HL at each frequency, 250-8000 Hz) Greater than or equal to 18 years of age at implantation Duration of moderate-to-profound sensorineural hearing loss less than or equal to 5 years [Either reported by subject or documented in previous audiograms] [Can be less than or equal to 10 years if the subject consistently utilized hearing technology (such as a bone conduction device or conventional hearing aid) within the past 5 years] Previous experience with a current treatment option for SSD, including a conventional hearing aid, bone-conduction device, or CROS/BICROS (Bilateral Contralateral Routing Of the Signal) technology. [At least one month of listening experience with device] [Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit] Aided word recognition in the ear to be implanted of 60% or less as measured with Consonant-Nucleus-Consonant (CNC) words (50-word list) [When listening with an appropriately fit hearing aid and masking applied to the contralateral ear] [Aided testing will be conducted in a sound-proof booth with the subject seated 1 meter from the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB Sound Pressure Level (SPL).] [The hearing aid output will be measured using National Acoustic Laboratory-NonLinear (NAL-NL1) targets.] Realistic expectations Willing to obtain recommended meningitis vaccinations per Center for Disease Control (CDC) recommendations No reported cognitive issues [Pass the Mini Mental State Examination (MMSE) screener] Able and willing to comply with study requirements, including travel to investigational site and study-related activities Exclusion Criteria (SSD): Non-native English speaker [Speech perception materials are presented in English] Conductive hearing loss in either ear Compromised auditory nerve, including those with a history of vestibular schwannoma Ossification Inability to participate in follow-up procedures (i.e., unwillingness, geographic location) History of meningitis, autoimmune disease, or any medical condition that contraindicate middle or inner ear surgery or anesthesia Meniere's disease with intractable vertigo Trauma that precludes inner ear surgery Case of sudden sensorineural hearing loss that has not been first evaluated by a physician Pregnancy [Subjects who are pregnant or become pregnant prior to surgery are excluded due to the potential risk of anesthesia to an unborn child.] [Subjects who become pregnant after surgery may continue to participate in study procedures] Tinnitus as the primary purpose for seeking cochlear implantation Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory (Newman, Jacobson & Spitzer, 1996). Inclusion Criteria (asymmetric hearing loss): a. Ear to be implanted i. Moderate-to-profound sensorineural hearing loss ii. PTA ≥70 dB HL iii. Aided word recognition of 60% or less as measured with CNC words (50-word list). b. Contralateral ear i. PTA ≥35 and ≤55 dB HL ii. Aided word recognition of 80% or more as measured with CNC words (50-word list). iii. Use of conventional amplification c. Greater than or equal to 18 years of age at implantation d. Duration of moderate-to-profound sensorineural hearing loss in the ear to be implanted is less than or equal to 5 years [Either reported by subject or documented in previous audiograms. Can be up to 10 years if the subject consistently utilized hearing technology in the ear to be implanted (such as a bone conduction device or conventional hearing aid) within the past 5 years] e. Previous experience with a current treatment option for asymmetric hearing loss, including a conventional hearing aid, bone-conduction device, or CROS/BiCROS technology. [At least one month of listening experience with device. Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit.] f. Realistic expectations g. Willing to obtain recommended meningitis vaccinations per CDC recommendations h. No reported cognitive issues [Pass the Mini Mental State Examination (MMSE) screener] i. Able and willing to comply with study requirements, including travel to investigational site and study-related activities Exclusion Criteria (Asymmetric hearing loss): Non-English speaker [Speech perception materials are presented in English] Medical condition considered a contraindication to undergoing cochlear implantation Conductive hearing loss in either ear Compromised auditory nerve, including those with a history of vestibular schwannoma Ossification Inability to participate in follow-up procedures (i.e., unwillingness, geographic location) History of meningitis, autoimmune disease, or any medical condition that contraindicate middle or inner ear surgery or anesthesia Meniere's disease with intractable vertigo Trauma that precludes inner ear surgery Case of sudden sensorineural hearing loss that has not been first evaluated by a physician Pregnancy [Subjects who are pregnant or become pregnant prior to surgery are excluded due to the potential risk of anesthesia to an unborn child. Subjects who become pregnant after surgery may continue to participate in study procedures] Tinnitus as the primary purpose for seeking cochlear implantation Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory (Newman, Jacobson & Spitzer, 1996).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margaret Dillon, AuD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27517

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21068690

Citation

Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271.

Results Reference

background

PubMed Identifier

22935813

Citation

Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d.

Results Reference

background

PubMed Identifier

24232066

Citation

Hansen MR, Gantz BJ, Dunn C. Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Meniere's disease. Otol Neurotol. 2013 Dec;34(9):1681-7. doi: 10.1097/MAO.0000000000000102.

Results Reference

background

PubMed Identifier

19005250

Citation

Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13.

Results Reference

background

PubMed Identifier

28375876

Citation

Dillon MT, Buss E, Anderson ML, King ER, Deres EJ, Buchman CA, Brown KD, Pillsbury HC. Cochlear Implantation in Cases of Unilateral Hearing Loss: Initial Localization Abilities. Ear Hear. 2017 Sep/Oct;38(5):611-619. doi: 10.1097/AUD.0000000000000430.

Results Reference

derived

Learn more about this trial

Cochlear Implantation in Cases of Single-Sided Deafness

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