Back to resultsDegree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook
Primary Purpose
Cochlear Implant, Cochlear Hearing Loss
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Advanced Bionics' Acoustic Earhook
Sponsored by
About this trial
This is an interventional treatment trial for Cochlear Implant
Eligibility Criteria
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.
Sites / Locations
- NYU Langone Health
Outcomes
Primary Outcome Measures
Change in Speech recognition testing, with and without acoustic earhook
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
Change in Sound quality judgements, with and without acoustic earhook
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
Change in Vocal emotion perception task, with and without acoustic earhook
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04041596
Brief Title
Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Due to a lack of enrollment
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cochlear Implant, Cochlear Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Advanced Bionics' Acoustic Earhook
Intervention Description
designed to deliver acoustic amplification through the modular attachment of the Naída CI Q90 AcoustiEarhook, while also delivering electrical stimulation along the full range of the implanted Advanced Bionics electrode.
Primary Outcome Measure Information:
Title
Change in Speech recognition testing, with and without acoustic earhook
Description
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
Time Frame
3 Months, 6 Months, 12 Months
Title
Change in Sound quality judgements, with and without acoustic earhook
Description
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
Time Frame
3 Months, 6 Months, 12 Months
Title
Change in Vocal emotion perception task, with and without acoustic earhook
Time Frame
3 Months, 6 Months, 12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Waltzman, MD
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook
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