Single-Sided Deafness and Asymmetric Hearing Loss

MED-EL

Status: Enrolling

Conditions: Hearing Loss, Sensorineural; Hearing Loss, Unilateral

Treatments: Device: MED-EL Cochlear Implant System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04506853

P000025/S113

Details and patient eligibility

About

The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.

Full description

The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.

Enrollment: 65 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Five 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 and a diagnosed pathology of the outer or middle ear
• Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 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 Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, 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
• Absence of cochlear development or non-functionality of cochlear nerve
• Other retrocochlear hearing loss
• Evidence of severe cochlear malformation (i.e., common cavity or ossification)
• External or middle ear infection
• Suspected developmental or cognitive concern
• Other medical contraindication for surgery or anesthesia

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Study Procedure

Other group

Treatment:

Device: MED-EL Cochlear Implant System