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

NCT ID: NCT04041596

Last Updated: 2020-05-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2020-03-17

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.

Conditions

Cochlear Implant; Cochlear Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Advanced Bionics' Acoustic Earhook

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Waltzman, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

18-01276

Identifier Type: -

Identifier Source: org_study_id