Status:
WITHDRAWN
Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook
Lead Sponsor:
NYU Langone Health
Conditions:
Cochlear Implant
Cochlear Hearing Loss
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04041596
Start Date
September 18 2018
End Date
March 17 2020
Last Update
May 29 2020
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016