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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Recruitment Status : Withdrawn (Due to a lack of enrollment)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

Tracking Information
First Submitted Date  ICMJE July 30, 2019
First Posted Date  ICMJE August 1, 2019
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE September 18, 2018
Actual Primary Completion Date March 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2019)
  • 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
  • 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
  • Change in Vocal emotion perception task, with and without acoustic earhook [ Time Frame: 3 Months, 6 Months, 12 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook
Official Title  ICMJE A Phase IV, Single-center Study of the Benefits of the Advanced Bionics Naída CI Q90 Acoustic Earhook in Adults Cochlear Implant Recipients.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cochlear Implant
  • Cochlear Hearing Loss
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 27, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2019)
30
Actual Study Completion Date  ICMJE March 17, 2020
Actual Primary Completion Date March 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04041596
Other Study ID Numbers  ICMJE 18-01276
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan Waltzman, MD New York Langone Health
PRS Account NYU Langone Health
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP