Clinical trial NCT04041596: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cochlear Implant
Cochlear Hearing Loss
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Speech recognition testing, with and without acoustic earhook
timeFrame: 3 Months, 6 Months, 12 Months
measure: Change in Sound quality judgements, with and without acoustic earhook
timeFrame: 3 Months, 6 Months, 12 Months
measure: Change in Vocal emotion perception task, with and without acoustic earhook
timeFrame: 3 Months, 6 Months, 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Susan Waltzman, MD
role: PRINCIPAL_INVESTIGATOR
References: