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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04041596
Recruitment Status : Withdrawn (Due to a lack of enrollment)
First Posted : August 1, 2019
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Cochlear Implant Cochlear Hearing Loss Device: Advanced Bionics' Acoustic Earhook Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : March 17, 2020
Actual Study Completion Date : March 17, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Change in Speech recognition testing, with and without acoustic earhook [ Time Frame: 3 Months, 6 Months, 12 Months ]
    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

  2. Change in Sound quality judgements, with and without acoustic earhook [ Time Frame: 3 Months, 6 Months, 12 Months ]
    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. Change in Vocal emotion perception task, with and without acoustic earhook [ Time Frame: 3 Months, 6 Months, 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041596


Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Susan Waltzman, MD New York Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04041596    
Other Study ID Numbers: 18-01276
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms