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

Republished By Plato
Republished By Plato

Date:

Views: 12
Node: 347644

Studies

Study First Submitted Date 2019-07-30
Study First Posted Date 2019-08-01
Last Update Posted Date 2020-05-29
Start Month Year September 18, 2018
Primary Completion Month Year March 17, 2020
Verification Month Year May 2020
Verification Date 2020-05-31
Last Update Posted Date 2020-05-29

Facilities

Sequence: 199643559
Name NYU Langone Health
City New York
State New York
Zip 10016
Country United States

Conditions

Sequence: 52070721 Sequence: 52070722
Name Cochlear Implant Name Cochlear Hearing Loss
Downcase Name cochlear implant Downcase Name cochlear hearing loss

Id Information

Sequence: 40078730
Id Source org_study_id
Id Value 18-01276

Countries

Sequence: 42476960
Name United States
Removed False

Interventions

Sequence: 52383257
Intervention Type Device
Name Advanced Bionics’ Acoustic Earhook
Description 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.

Design Outcomes

Sequence: 177032881 Sequence: 177032882 Sequence: 177032883
Outcome Type primary Outcome Type primary Outcome Type primary
Measure Change in Speech recognition testing, with and without acoustic earhook Measure Change in Sound quality judgements, with and without acoustic earhook Measure Change in Vocal emotion perception task, with and without acoustic earhook
Time Frame 3 Months, 6 Months, 12 Months Time Frame 3 Months, 6 Months, 12 Months Time Frame 3 Months, 6 Months, 12 Months
Description 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 Description 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

Browse Conditions

Sequence: 193085786 Sequence: 193085787 Sequence: 193085788 Sequence: 193085789 Sequence: 193085790 Sequence: 193085791 Sequence: 193085792 Sequence: 193085793
Mesh Term Hearing Loss Mesh Term Hearing Loss, Sensorineural Mesh Term Hearing Disorders Mesh Term Ear Diseases Mesh Term Otorhinolaryngologic Diseases Mesh Term Sensation Disorders Mesh Term Neurologic Manifestations Mesh Term Nervous System Diseases
Downcase Mesh Term hearing loss Downcase Mesh Term hearing loss, sensorineural Downcase Mesh Term hearing disorders Downcase Mesh Term ear diseases Downcase Mesh Term otorhinolaryngologic diseases Downcase Mesh Term sensation disorders Downcase Mesh Term neurologic manifestations Downcase Mesh Term nervous system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48225857
Agency Class OTHER
Lead Or Collaborator lead
Name NYU Langone Health

Overall Officials

Sequence: 29226448
Role Principal Investigator
Name Susan Waltzman, MD
Affiliation New York Langone Health

Eligibilities

Sequence: 30706660
Gender All
Minimum Age 18 Years
Maximum Age 99 Years
Healthy Volunteers No
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.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253927436
Number Of Facilities 1
Registered In Calendar Year 2019
Actual Duration 18
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 99
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3

Designs

Sequence: 30453266
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28819737
Responsible Party Type Sponsor

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