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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02532972
Other study ID # 13-054H
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date April 25, 2019

Study information

Verified date April 2020
Source Massachusetts Eye and Ear Infirmary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided deafness).


Description:

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Study Design


Intervention

Device:
Med-el MAESTRO Cochlear Implant with Flex 28 electrode array
Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.

Locations

Country Name City State
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Dr. Daniel Lee University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (17)

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Outcome

Type Measure Description Time frame Safety issue
Primary Sound Detection Via Pure-tone Threshold Audiometry (PTA) Sound field thresholds following cochlear implantation via pure-tone threshold audiometry. Measured in dB HL (decibels hearing level) where a lower number means more sensitive hearing and a higher number means less sensitive hearing. 3, 6 and 12 months post-operatively
Primary Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing Ability to recognize words and sentences read by the tester from a set list at a loudness of 65 dB HL. The outcome is measured as a percent score of words recognized. The test takes place in a quiet environment. Preop, 1-4 weeks, and 3, 6, and 12 months post-operatively
Secondary Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI) Tinnitus severity rated by the Tinnitus Handicap Index (THI). The THI score of 0-16 means "no or slight handicap", 18 to 36 indicates "mild", 38 to 56 indicates "moderate", 58 to 76 indicates "severe", and a score of 78-100 is classified as "catastrophic handicap" Preop and 12 months post-operatively
See also
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