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Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook

Sponsor
NYU Langone Health (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04041596
Collaborator
(none)
0
Enrollment
1
Location
17.9
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to obtain a greater understanding of the range in benefit from acoustic amplification combined with electric stimulation in cochlear implant recipients with low-frequency hearing who do not currently use the commercially approved Advanced Bionics Acoustic Earhook. The aims of this study are to 1) obtain subjective sound quality judgements of recorded speech and music samples, 2) assess vocal emotion perception, and 3) evaluate post-operative speech perception and sound field detection thresholds in CI recipients both with and without use of the acoustic ear hook.

Condition or Disease Intervention/Treatment Phase
  • Device: Advanced Bionics' Acoustic Earhook
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IV, Single-center Study of the Benefits of the Advanced Bionics Naída CI Q90 Acoustic Earhook in Adults Cochlear Implant Recipients.
Actual Study Start Date :
Sep 18, 2018
Actual Primary Completion Date :
Mar 17, 2020
Actual Study Completion Date :
Mar 17, 2020

Outcome Measures

Primary Outcome Measures

  1. Change in Speech recognition testing, with and without acoustic earhook [3 Months, 6 Months, 12 Months]

    5-alternative identification task to measure vocal emotion recognition (Toronto Emotional Speech Test (TESS) at initial fitting, and 3, 6, and 12 months after fitting

  2. Change in Sound quality judgements, with and without acoustic earhook [3 Months, 6 Months, 12 Months]

    Ratings of sound quality (Judgement of Sound Quality {JSQ} test) of speech and music samples at initial fitting, and 3, 6, and 12 months after fitting

  3. Change in Vocal emotion perception task, with and without acoustic earhook [3 Months, 6 Months, 12 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Ability to provide informed consent

  • Implanted with an Advanced Bionics Advanced Bionics HiRes Ultra, 90K, or CII implant, and using a Naída Q90 sound processor

  • 18 years of age or older with post-lingual hearing loss

  • Aided open-set speech recognition scores greater than 30% correct in quiet in the ear to be tested

  • Unaided low frequency audiometric hearing thresholds of 90 dB HL or better at .125, .25, and .5 kHz

  • Participants must have a working understanding of and ability to verbalize in English as the evaluation measures are available exclusively in English

  • Willingness to use an acoustic component with their ear-level sound processor postoperatively for the duration of the study

  • Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

  • Exclusive use of a body worn external sound processor

  • Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear

  • Postoperative unaided low frequency audiometric hearing thresholds in the implanted ear exceeding 90 dB HL at any frequency from 125 - 500 Hz.

  • Presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation or outcomes measures.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Susan Waltzman, MD, New York Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04041596
Other Study ID Numbers:
  • 18-01276
First Posted:
Aug 1, 2019
Last Update Posted:
May 29, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural

Study Results

No Results Posted as of May 29, 2020