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Cochlear Implantation for Treatment of Single-sided Deafness

Primary Purpose

Total Unilateral Deafness, Unilateral Partial Deafness

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Med-el MAESTRO Cochlear Implant with Flex 28 electrode array

About this trial

This is an interventional treatment trial for Total Unilateral Deafness

Eligibility Criteria

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

Inclusion Criteria:

18 years of age or older with the ability to provide informed consent
English as the primary language
Medically and psychologically suitable
Willing to receive/have received meningitis vaccinations
Able to pay for all care received through the study, either through the subject's insurance company or through self-pay
Able to comply with study requirements, including travel to the investigational sites
Severe to profound sensorineural hearing loss (≥70 dB HL (decibel hearing level) thresholds between 500 and 4000 Hz) in the worse ear with ≤ 20% Consonant-Nucleus-Consonant (CNC) word scores
Duration of single-sided deafness ≥ one year
Tinnitus localized to the affected ear, both ears, or in the head localized to the affected ear, both ears, or in the head
- Expected subjects include those with:
Unilateral hearing loss secondary to viral or bacterial infection, such as meningitis or labyrinthitis
Ménière's disease
Sudden sensorineural hearing loss
Vascular disease affecting the inner ear
A combination of any number of the above conditions

Exclusion Criteria:

Duration of single-sided deafness ≥ ten years
Pure tone thresholds ≥ 35 dB HL at 500, 1000, 2000, and 4000 Hz in the better ear
Consonant-Nucleus-Consonant (CNC) word scores ≤ 70% in the better ear
Chronic otitis media in either ear
Inner ear malformation in either ear
Autoimmune inner ear disease (fluctuation sensorineural hearing loss in either ear)
Evidence of retrocochlear pathology, including vestibular schwannoma
Unilateral tinnitus in the unaffected ear
Cochlear ossification
Demonstrated cognitive and/or developmental challenges
Major depression or anxiety; post-traumatic stress disorder; substance abuse
Medical or psychological conditions that serve as contraindication to surgery
Additional handicaps that would prevent or limit participation in evaluations
Unrealistic patient or family expectations regarding the benefits, risks, and limitations inherent to the procedure and the prosthetic device
Pregnant women: The investigators will specifically ask all women of childbearing age if there is a possibility they are pregnant or trying to become pregnant at the initial clinic visit; any women who are pregnant or actively trying to become pregnant will be excluded. In cases that are questionable on the day of planned surgery, a pregnancy test will be performed as per current Massachusetts Eye & Ear Infirmary anesthesia pre-operative protocols.

Sites / Locations

Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cochlear Implant surgery

Arm Description

All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array

Outcomes

Primary Outcome Measures

Sound Detection Via Pure-tone Threshold Audiometry (PTA)

Sound field thresholds following cochlear implantation via pure-tone threshold audiometry. Measured in dB HL (decibels hearing level) where a lower number means more sensitive hearing and a higher number means less sensitive hearing.

Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing

Ability to recognize words and sentences read by the tester from a set list at a loudness of 65 dB HL. The outcome is measured as a percent score of words recognized. The test takes place in a quiet environment.

Secondary Outcome Measures

Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI)

Tinnitus severity rated by the Tinnitus Handicap Index (THI). The THI score of 0-16 means "no or slight handicap", 18 to 36 indicates "mild", 38 to 56 indicates "moderate", 58 to 76 indicates "severe", and a score of 78-100 is classified as "catastrophic handicap"

Full Information

NCT ID

NCT02532972

First Posted

August 14, 2015

Last Updated

April 23, 2020

Sponsor

Dr. Daniel Lee

Collaborators

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT02532972

Brief Title

Cochlear Implantation for Treatment of Single-sided Deafness

Official Title

Cochlear Implantation for Treatment of Single-sided Deafness

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Terminated

Why Stopped

Closed by IRB

Study Start Date

September 2015 (Actual)

Primary Completion Date

February 27, 2019 (Actual)

Study Completion Date

April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Daniel Lee

Collaborators

University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided deafness).

Detailed Description

The goal of this study is to further investigate the role of CI in treating unilateral hearing loss and associated tinnitus. Single-sided deafness (SSD) afflicts approximately 60,000 new patients per year in the United States. The most common causes of these single-sided losses are sudden sensorineural hearing loss, Meniere's disease, trauma, and vestibular schwannoma. Patients with SSD face significant difficulty with communicating in the presence of background noise and in sound localization. Another significant problem for some SSD patients is tinnitus, which can be incapacitating and for which there are no therapies available that are considered to be of sufficient reliability to become a standard of care. Difficulty hearing in background noise and increased tinnitus can lead to significant frustration in social situations and contribute to increased isolation and a decreased quality of life. Treatment options for single sided deafness in the United States include contralateral routing of signals (CROS) hearing aids, bone-anchored hearing aids (BAHA) and use of assistive devices to improve the signal-to-noise in group situations. The first two devices take sound from the affected ear and transmit it to the unaffected ear. The last device consists of having a speaker wear a microphone and routing the signal directly to the patient's ear at a louder listening level. Although these devices can improve speech understanding in some patients, studies have shown that use of these devices does not ameliorate tinnitus or sound localization difficulties. Recent European studies have demonstrated that cochlear implantation (CI) can provide significant improvements in both perceived hearing ability and measured speech comprehension and localization in adult and pediatric patients with unilateral hearing loss. This suggests that CI may be a more effective option for this patient population than the CROS, BAHA or assistive devices.

6. Conditions and Keywords

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

Total Unilateral Deafness, Unilateral Partial Deafness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cochlear Implant surgery

Arm Type

Experimental

Arm Description

All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array

Intervention Type

Device

Intervention Name(s)

Med-el MAESTRO Cochlear Implant with Flex 28 electrode array

Other Intervention Name(s)

CI, cochlear implant

Intervention Description

Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.

Primary Outcome Measure Information:

Title

Sound Detection Via Pure-tone Threshold Audiometry (PTA)

Description

Time Frame

3, 6 and 12 months post-operatively

Title

Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing

Description

Time Frame

Preop, 1-4 weeks, and 3, 6, and 12 months post-operatively

Secondary Outcome Measure Information:

Title

Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI)

Description

Time Frame

Preop and 12 months post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age or older with the ability to provide informed consent English as the primary language Medically and psychologically suitable Willing to receive/have received meningitis vaccinations Able to pay for all care received through the study, either through the subject's insurance company or through self-pay Able to comply with study requirements, including travel to the investigational sites Severe to profound sensorineural hearing loss (≥70 dB HL (decibel hearing level) thresholds between 500 and 4000 Hz) in the worse ear with ≤ 20% Consonant-Nucleus-Consonant (CNC) word scores Duration of single-sided deafness ≥ one year Tinnitus localized to the affected ear, both ears, or in the head localized to the affected ear, both ears, or in the head Expected subjects include those with: Unilateral hearing loss secondary to viral or bacterial infection, such as meningitis or labyrinthitis Ménière's disease Sudden sensorineural hearing loss Vascular disease affecting the inner ear A combination of any number of the above conditions Exclusion Criteria: Duration of single-sided deafness ≥ ten years Pure tone thresholds ≥ 35 dB HL at 500, 1000, 2000, and 4000 Hz in the better ear Consonant-Nucleus-Consonant (CNC) word scores ≤ 70% in the better ear Chronic otitis media in either ear Inner ear malformation in either ear Autoimmune inner ear disease (fluctuation sensorineural hearing loss in either ear) Evidence of retrocochlear pathology, including vestibular schwannoma Unilateral tinnitus in the unaffected ear Cochlear ossification Demonstrated cognitive and/or developmental challenges Major depression or anxiety; post-traumatic stress disorder; substance abuse Medical or psychological conditions that serve as contraindication to surgery Additional handicaps that would prevent or limit participation in evaluations Unrealistic patient or family expectations regarding the benefits, risks, and limitations inherent to the procedure and the prosthetic device Pregnant women: The investigators will specifically ask all women of childbearing age if there is a possibility they are pregnant or trying to become pregnant at the initial clinic visit; any women who are pregnant or actively trying to become pregnant will be excluded. In cases that are questionable on the day of planned surgery, a pregnancy test will be performed as per current Massachusetts Eye & Ear Infirmary anesthesia pre-operative protocols.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel J Lee, MD, FACS

Organizational Affiliation

MEEI / MGH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts Eye and Ear Infirmary

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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Citation

Arts RA, George EL, Stokroos RJ, Vermeire K. Review: cochlear implants as a treatment of tinnitus in single-sided deafness. Curr Opin Otolaryngol Head Neck Surg. 2012 Oct;20(5):398-403. doi: 10.1097/MOO.0b013e3283577b66.

Results Reference

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Citation

Bishop CE, Eby TL. The current status of audiologic rehabilitation for profound unilateral sensorineural hearing loss. Laryngoscope. 2010 Mar;120(3):552-6. doi: 10.1002/lary.20735.

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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.

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Citation

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Cochlear Implantation for Treatment of Single-sided Deafness

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