Single-Sided Deafness in the Medicare Population

  • STATUS
    Recruiting
  • End date
    Apr 14, 2024
  • participants needed
    15
  • sponsor
    Med-El Corporation
Updated on 14 July 2022
Accepts healthy volunteers

Summary

The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.

Description

The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will recruit subjects into this study. Study subjects will be followed for 12 months post-implantation of the device.

Details
Condition Hearing Loss, Unilateral
Treatment MED-EL Cochlear Implant System
Clinical Study IdentifierNCT05250414
SponsorMed-El Corporation
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years of age or older at the time of implantation
Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz
Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less
Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
Previous experience with an appropriately-fit CROS, BI-CROS, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
Fluent in English

Exclusion Criteria

Duration of profound hearing loss of 10 years or more
Sudden onset of hearing loss within six months of implantation
Evidence of non-functional cochlear nerve or other retrocochlear hearing loss
Evidence of severe cochlear malformation (i.e., common cavity or ossification)
External or middle ear infection
Suspected cognitive concern
Other medical contraindication for surgery or anesthesia
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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