Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook
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ClinicalTrials.gov Identifier: NCT04041596
Recruitment Status :
(Due to a lack of enrollment)
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.