Clinical trial NCT03236909: Expanded Indications in the Adult Cochlear Implant Population
Official title: Expanded Indications in the Adult Cochlear Implant Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Percent correct words recognition in quiet in implanted ear
timeFrame: Up to twelve (12 months) post-activation
measure: Percent correct of words identified for sentences in noise in implanted ear
timeFrame: Up to twelve (12 months) post-activation
Secondary outcomes:
measure: Patient reported improvement in everyday listening conditions
timeFrame: Up to twelve (12 months) post -activation
measure: Number and proportion of subjects experiencing device related adverse events
timeFrame: Up to twelve (12 months) post-activation
measure: Residual low frequency hearing
timeFrame: Up to twelve (12) months post-activation
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
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