Single-Sided Deafness in the Medicare Population

Med-El Corporation18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss, Unilateral

Interventions

MED-EL Cochlear Implant SystemDEVICE

Cochlear implant and audio processor

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 65 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

Locations (3)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Activation.

The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. AzBio sentences in noise will be administered at 60 dB SPL with a signal-to-noise ratio of 0 dB SNR. Pre-operatively, sentence testing will occur with a CROS hearing aid. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise. AzBio sentences in noise are scored as a percentage of words correctly repeated back out of the total number of words presented on the list (range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.

Time frame: One year (12 months) post activation

Secondary Outcomes

Performance of the Cochlear Implant System Will be Summarized Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Implantation.

Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 6- and 12-months post activation. AzBio sentences in noise will be administered at 60 dB SPL with a signal-to-noise ratio of 0 dB SNR. Pre-operatively, sentence testing will occur with a CROS hearing aid. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise. AzBio sentences in noise are scored as a percentage of words correctly repeated back out of the total number of words presented on the list (range of score 0-100, higher score is better). Percentage point change from baseline is reported where a positive change represents an improvement from baseline and a negative change represents a decrement from baseline.

Time frame: One year (12 months) post implantation

Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Quiet Completed Through One Year (12 Months ) Post Implantation.

Speech perception in quiet will be summarized for the CI ear at the pre-operative, 6-month, and 12-month intervals, and for the contralateral ear at the pre-operative and 12-month intervals. One 50-word CNC Words list will be used to assess speech perception in quiet at each visit, scored as the percent of words repeated correctly out of the total words presented (range of 0-100, higher is better). Percentage point change from baseline is reported where a positive change represents an improvement from baseline and a negative change represents a decrement from baseline.

Data from ClinicalTrials.gov

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