Expanded Indications in the Adult Cochlear Implant Population

Study Overview
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Brief Summary
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The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.

Detailed Description
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Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. . Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.

Official Title
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Expanded Indications in the Adult Cochlear Implant Population

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Device: MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, 18 years of age or older at the time of implantation Moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: Low-frequency PTA (250, 500, and 1000 Hz) greater than 40 dB High-frequencies not better than 65 dB (3000 Hz - 8000 Hz) Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10dB Limited benefit from appropriately fit hearing aids, defined by CNC word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear CNC word score in quiet of greater than or equal to 10% in the ear to be implanted Evidence of appropriately fit hearing aids as determined by the audiologist Bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal Hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification If appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study Fluent in English No radiological contraindications Ability to undergo general anesthesia Appropriate motivation and expectation levels Stated willingness to comply with all study procedures for the duration of the study Exclusion Criteria: Evidence that hearing loss is retrocochlear in origin Active middle ear infection Skin or scalp condition precluding use of external audio processor- Suspected cognitive impairment or organic brain dysfunction History of prior use of a hearing implant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm<br>Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant | Device: MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System<br>* Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.<br>* Other names: SYNCHRONY +FLEX28;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent correct words recognition in quiet in implanted ear | CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline through 6 months and reported as percentage points improved. | Up to twelve (12 months) post-activation | 
| Percent correct of words identified for sentences in noise in implanted ear | AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline through 6 months and reported as percentage points improved. | Up to twelve (12 months) post-activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported improvement in everyday listening conditions | APHAB (ABBREVIATED PROFILE OF HEARING AID BENEFIT) and SSQ (Spatial and Qualities of Hearing) questionnaires will be used to assess subjective outcomes and reported as improvements from baseline to 6 months post-activation. | Up to twelve (12 months) post -activation | 
| Number and proportion of subjects experiencing device related adverse events | Adverse events will be collected and reported throughout the duration of the study. | Up to twelve (12 months) post-activation | 
| Residual low frequency hearing | HEARRING scale will be used to calculate the percent of hearing preservation for each subject. This data will be summarized through 6 months post-activation. | Up to twelve (12) months post-activation |