Expanded Indications in the Adult Cochlear Implant Population

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear	6 months post-activation	AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline.
Change in Percent Correct on Word Recognition in Quiet in Implanted Ear	6 months post-activation	CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition	6 months post-activation	APHAB (ABBREVIATED PROFILE OF HEARING AID BENEFIT) questionnaire will be used to assess subjective outcomes and reported as change in mean Global Score at 6 months post-activation compared to baseline. Letter responses from A to G on each question have a percent value, and the Global Score is an average percent value of all letters. A lower score shows less difficulty (better performance).
Number of Participants Experiencing an Adverse Device Effect (ADE)	Through study completion, or at least 1 year, 4 months post-implantation	Adverse device effects will be collected for all participants through study completion and reported as the number of participants experiencing an ADE.
Number of Participants With Residual Low-frequency Hearing	6 months post-activation	HEARRING scale will be used to calculate the percent of hearing preservation for each subject by comparing average hearing thresholds from 125 to 1000 Hz at 6 months post-activation to the average at baseline.
Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition	6 months post-activation	The SSQ (Spatial and Qualities of Hearing) questionnaire will be used to assess subjective outcomes and reported as change in mean Overall Score at 6 months post-activation compared to baseline. SSQ is scored on a 10-point Likert scale where 10 shows better listening skills/experiences than 0.

Locations (5): University of Miami
🇺🇸
Miami, Florida, United States
University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States
Vanderbilt University
🇺🇸
Nashville, Tennessee, United States
Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
Sunnybrook Health Sciences Centre
🇨🇦
Toronto, Ontario, Canada
University of Miami
🇺🇸Miami, Florida, United States