Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants

Completed

• Conditions: Hearing Loss, Unilateral; Hearing Loss, Profound
• Interventions: Device: Cochlear Implant

• Registration Number: NCT03929809
• Lead Sponsor: University of Iowa

Brief Summary

The purpose of this study is to understand the speech perception in noise and in quiet and localization benefits in a laboratory setting in listeners that receive a cochlear implant in an ear with severe to profound hearing loss and have normal, or near-normal hearing in the opposite ear. We will also evaluate the functional benefit of restoring hearing to the impaired ear via questionnaires that subjects will be answering while listening in their natural environment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Study Start: 2019-06-20
• Status Verified: 2020-09
• Primary Completion: 2021-08-18
• Study Completion: 2021-08-18
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Participants will be adults who utilize English as their primary language.
2. Unilateral severe to profound sensorineural hearing loss for a duration of at least 6 months (to ensure stability of hearing loss), but no greater than 10 years.
3. Contralateral ear with normal, or near-normal, hearing.
4. Poorer ear (ear to be implanted): severe to profound sensorineural hearing loss, defined as pure-tone thresholds 70 dB HL or greater for the frequencies 500, 1000, 2000, 3000, and 4000 Hz with monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, less than or equal to 20%
5. Better ear (contralateral ear): normal or near-normal hearing defined as pure-tone thresholds no poorer than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB HL at 4000 Hz with monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, of greater than or equal to 85%.
6. Willingness to comply with all study requirements.
7. Patent cochlea and normal cochlear anatomy.

Exclusion Criteria

1. Medical or psychological conditions that contraindicate undergoing surgery.
2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
3. Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
4. Unwillingness or inability of the candidate to comply with all investigational requirements.
5. Active middle ear infection.
6. Tinnitus primary motivation for implantation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult Single-sided deafness	Cochlear Implant	Adult subjects with unilateral single-sided deafness at least 6 months (to ensure stability of hearing loss), but no greater than 10 years will be implanted with a MED-EL Synchrony Cochlear Implant.

Primary Outcome Measures

Name	Time	Method
Change in AzBio Sentences in Noise	Pre-operative baseline, 3, 6, 12 months post-activation	The percent correct of words from a list of 20 Target AzBio sentences will be played from 0° azimuth. A list of AzBio sentences will be played in multitalker babble which will be presented in three different conditions: 0° azimuth, S0N90, or S0N270°.
Change in Localization	Pre-operative baseline, 3, 6, 12 months post-activation	Testing with 16 sounds played randomly from 1 of 8 loudspeakers in a 108 degree arc will be completed with non-implanted ear alone and everyday listening condition at 60 dBA. Subjects will be asked to identify which loudspeaker presented the sound. The RMS error in degrees will be calculated. A lower number indicates better localization ability.

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States