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

Cochlear Hearing Loss Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04041596
• Other study ID #: 18-01276
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 18, 2018
• Est. completion date: March 17, 2020

Study information

• Verified date: May 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Cochlear Implant
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 Months, 6 Months, 12 Months
Primary	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	3 Months, 6 Months, 12 Months
Primary	Change in Vocal emotion perception task, with and without acoustic earhook		3 Months, 6 Months, 12 Months