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

Hearing Loss, Unilateral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929809
• Other study ID #: 201901735
• Status: Completed
• Start date: June 20, 2019
• Est. completion date: August 18, 2021

Study information

• Verified date: September 2020
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 18, 2021
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Profound
• Hearing Loss, Unilateral

Intervention

Device:
• Cochlear Implant
adults with unilateral hearing loss who wish to regain bilateral hearing will be implanted with a cochlear implant on their deafened ear.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AzBio Sentences in Noise	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°.	Pre-operative baseline, 3, 6, 12 months post-activation
Primary	Change in Localization	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.	Pre-operative baseline, 3, 6, 12 months post-activation