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Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents

Primary Purpose

Hearing Loss, High-Frequency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cochlear® Nucleus™ Hybrid L24

Cochlear® Nucleus™ Hybrid S12

About this trial

This is an interventional treatment trial for Hearing Loss, High-Frequency focused on measuring residual hearing, hybrid, hearing preservation

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1.1 Criteria for Inclusion in Population 1

Criterion for selection will be subject interest in preservation of residual hearing; severe sensorineural hearing loss; lack of benefit from appropriately fit binaural hearing aids worn on a full-time basis; and realistic expectations. Qualified participants must also meet the following criteria for inclusion:

Eighteen year of age or older at the time of implantation.
Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted.
Speech Perception:
- The Consonant-Nucleus-Consonant (CNC) word recognition score between 0% and 35% inclusive in the ear to be implanted.
- The CNC word recognition score in the contralateral ear equal to or better than, in the ear to be implanted but not more than 60% in the best-aided condition.
English spoken as a primary language.
Willingness to comply with all study requirements.
Minimum of 30 day hearing aid trial with appropriately fit hearing aids worn on a full-time basis (8 hours per day).
Patent cochlea and normal cochlear anatomy.

1.2 Criteria for Inclusion in Population 2

Criterion for selection will be parent interest in preservation of residual hearing; severe post-lingual onset of sensorineural hearing loss; lack of benefit from appropriately fit binaural hearing aids worn on a full-time basis; and supportive family dynamics. Qualified participants must also meet the following criteria for inclusion:

Five to fifteen years of age at the time of implantation.
Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted.
Speech Perception:
- The Phonetically Balanced-Kindergarten (PB-K) word recognition score between 0% and 50% inclusive in the ear to be implanted.
- The PB-K word recognition score in the contralateral ear equal to or better than, in the ear to be implanted but not more than 60%.
English spoken as a primary language.
Willingness to comply with all study requirements.
Minimum of 30-day hearing aid trial with appropriately fit hearing aids worn on a full-time basis (8 hours per day)..
Patent cochlea and normal cochlear anatomy.
Must be in a habilitation/educational program with an emphasis on spoken language development.

Exclusion Criteria:

1.3 Criteria for Exclusion in Populations 1 and 2

Medical or psychological conditions that contraindicate undergoing surgery.
Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
Unwillingness or inability of the candidate to comply with all investigational requirements.
Active middle ear infection.

Sites / Locations

University of Iowa Hospitals and Clinics
University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Adult

Children and adolescents (L24)

Children and adolescents S12

Arm Description

Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid L24 cochlear implant.

Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold >90 dB HL at 1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid L24 cochlear implant.

Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid S12 cochlear implant.

Outcomes

Primary Outcome Measures

Change in CNC Word Perception

Pre-operatively, speech perception testing will be conducted using the ear implanted and bilaterally with appropriately fit hearing aids. Post-operatively, speech perception testing will be attempted in the following conditions (unless otherwise noted): Combined stimulation (cochlear implant and any hearing aids worn on the implanted or non-implanted ears) Testing will be in quiet at 60 dB(A). The CNC word perception test consists of multiple lists of 50 3-syllable words (consonant-nucleus-consonant) that are presented through a loudspeaker using an open set format. Percent correct is calculated by the number of words identified by the subject out of the 50 words presented.

Secondary Outcome Measures

Change in Localization

Pre-operatively and post-operative, testing will be conducted using bilaterally fitted devices (preoperatively) and a cochlear implant and bilateral hearing aids (if applicable) postoperatively (combined condition). Everyday sounds will be presented from one of eight loudspeakers at 60 dBA forming a 108- arc. The participant will face the center of the speaker array at a 1.4 m. 16 different sounds will be repeated 6 times and presented randomly from one of the loudspeakers. Localization performance was calculated by the average root-mean-square (RMS) error in degrees.

AzBio +5 Noise

Sentences in a +5 dB noise will be administered. Sentences will be tested at 60 dB(A) and noise at 55 dB(A) from the front. Pre-operatively, speech perception testing will be conducted using the ear implanted and bilaterally with appropriately fit hearing aids. Post-operatively, speech perception testing will be attempted in the following conditions (unless otherwise noted): Combined stimulation (cochlear implant and any hearing aids worn on the implanted or non-implanted ears) The AzBio sentence perception test consists of multiple lists of 20 sentences that are presented in sound-field from a loudspeaker using an open set format. Percent correct is calculated by the number of words correctly identified by the subject out of the total number of words presented in the sentence lists.

Full Information

NCT ID

NCT01975571

First Posted

July 6, 2012

Last Updated

May 16, 2022

Sponsor

Bruce J Gantz

1. Study Identification

Unique Protocol Identification Number

NCT01975571

Brief Title

Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents

Official Title

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

July 2011 (Actual)

Primary Completion Date

September 8, 2018 (Actual)

Study Completion Date

September 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bruce J Gantz

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine if adults and children with residual low-pitch hearing in the severe hearing loss range can develop improved speech perception by combining their residual acoustic hearing with electrical stimulation through a short cochlear implant. The low-pitches would be amplified with a hearing aid and the high-pitch sounds would be stimulated electrically.

Detailed Description

The purpose of this study is to determine if individuals with residual low-frequency hearing in the severe range can develop improved speech perception by combining their residual acoustic hearing with electrical processing through a cochlear implant designed to stimulate the high-frequency basal and middle turn of the cochlea while preserving useful low-frequency acoustic hearing. To accomplish this, we propose to implant individuals with severe hearing with a Cochlear® Nucleus™ Hybrid L24 Implant or a Cochlear® Nucleus™ Hybrid S12 in the poorer ear. We believe these devices will do less damage to the Organ of Corti structures, than longer, more invasive standard cochlear implant electrodes. Two different populations will be studied under this IDE. Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 decibels (dB) hearing level (HL) between 125-1500 Hz and profound loss at higher frequencies will be implanted with the Cochlear® Nucleus™ Hybrid L24 Implant. The potential subject will present with Consonant-Nucleus-Consonant (CNC) monosyllabic word scores between 0-35% in the ear to be implanted and up to 60% understanding in the contralateral ear in the best-aided condition. Population 2: 30 Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies will be implanted with the Cochlear® Nucleus™ Hybrid L24 Implant or the Cochlear® Nucleus™ Hybrid S12 Implant. Those that have hearing thresholds between 60-90 dB HL at 1500 Hz would be implanted with the less invasive shorter 10 mm Hybrid S12 in attempt to better preserve the middle frequency range. Those with hearing thresholds >90 dB HL at 1500 Hz would receive the longer 16 mm Hybrid L24 electrode. The potential subject will present with Phonetically Balanced Kindergarten (PB-K) monosyllabic word scores between 0-50% in the ear to be implanted and up to 60% understanding in the contralateral ear in the best-aided condition. Through the preserved acoustic hearing, we believe the subject will experience better signal to noise ratios for speech perception in noise, better localization of sound and an improvement music perception. Histological evidence from patients implanted with standard arrays and our experience with a short electrode array for implantation of individuals with significant residual hearing both support this assumption (Nadol, Shiao, Burgess, Ketten, Eddington et al., 2001). The duration of this study will be 2 years (24 months) for adults and for 5 years (60 months) in children and adolescents.

6. Conditions and Keywords

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

Hearing Loss, High-Frequency

Keywords

residual hearing, hybrid, hearing preservation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adult

Arm Type

Experimental

Arm Description

Arm Title

Children and adolescents (L24)

Arm Type

Experimental

Arm Description

Arm Title

Children and adolescents S12

Arm Type

Experimental

Arm Description

Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid S12 cochlear implant.

Intervention Type

Device

Intervention Name(s)

Cochlear® Nucleus™ Hybrid L24

Intervention Description

The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.

Intervention Type

Device

Intervention Name(s)

Cochlear® Nucleus™ Hybrid S12

Intervention Description

The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.

Primary Outcome Measure Information:

Title

Change in CNC Word Perception

Description

Time Frame

pre-op, 3, 6, 12, 24 months in the adults and pre-op, 3, 6, 12, 24, 36, 48, and 60 months post-implantation for children

Secondary Outcome Measure Information:

Title

Change in Localization

Description

Time Frame

Preoperatively and at 6 and 24 months post op in adults and pre op and 12 and 24 mos in children

Title

AzBio +5 Noise

Description

Time Frame

Adults pre-op, 3, 6, 12, 24 months post op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1.1 Criteria for Inclusion in Population 1 Criterion for selection will be subject interest in preservation of residual hearing; severe sensorineural hearing loss; lack of benefit from appropriately fit binaural hearing aids worn on a full-time basis; and realistic expectations. Qualified participants must also meet the following criteria for inclusion: Eighteen year of age or older at the time of implantation. Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted. Speech Perception: The Consonant-Nucleus-Consonant (CNC) word recognition score between 0% and 35% inclusive in the ear to be implanted. The CNC word recognition score in the contralateral ear equal to or better than, in the ear to be implanted but not more than 60% in the best-aided condition. English spoken as a primary language. Willingness to comply with all study requirements. Minimum of 30 day hearing aid trial with appropriately fit hearing aids worn on a full-time basis (8 hours per day). Patent cochlea and normal cochlear anatomy. 1.2 Criteria for Inclusion in Population 2 Criterion for selection will be parent interest in preservation of residual hearing; severe post-lingual onset of sensorineural hearing loss; lack of benefit from appropriately fit binaural hearing aids worn on a full-time basis; and supportive family dynamics. Qualified participants must also meet the following criteria for inclusion: Five to fifteen years of age at the time of implantation. Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be implanted. Speech Perception: The Phonetically Balanced-Kindergarten (PB-K) word recognition score between 0% and 50% inclusive in the ear to be implanted. The PB-K word recognition score in the contralateral ear equal to or better than, in the ear to be implanted but not more than 60%. English spoken as a primary language. Willingness to comply with all study requirements. Minimum of 30-day hearing aid trial with appropriately fit hearing aids worn on a full-time basis (8 hours per day).. Patent cochlea and normal cochlear anatomy. Must be in a habilitation/educational program with an emphasis on spoken language development. Exclusion Criteria: 1.3 Criteria for Exclusion in Populations 1 and 2 Medical or psychological conditions that contraindicate undergoing surgery. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array. Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices. Unwillingness or inability of the candidate to comply with all investigational requirements. Active middle ear infection.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Gantz, MD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

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Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents

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