Single-Sided Deafness and Asymmetric Hearing Loss

ID#: NCT04506853

Age: 5 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: February 22, 2021

End Date: September 01, 2026

Summary: 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.
Eligibility:

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
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