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Super Power in BAI

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ClinicalTrials.gov Identifier: NCT03118375
Recruitment Status : Terminated (Could not adequately recruit enough subjects to reach appropriate sample size)
First Posted : April 18, 2017
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Hillary A snapp, University of Miami

Brief Summary:
The purpose of this study is to assess the benefit of new super-power bone-anchored hearing aid (BAHA) processors in BAHA users. BAHAs are able to help people with mixed/conductive and single-sided hearing loss when they are unable to use or receive limited benefit from traditional hearing. Until recently, BAHAs were only recommended to people with up to a moderate hearing loss. New super-power BAHA processors may be able to help people who previously were not candidates for BAHAs or received limited benefit from them. The information collected in this study may lead to improved evaluation of and expanded treatment options for people considering BAHA. Different types of hearing tests will be used to compare the devices.

Condition or disease Intervention/treatment
Conductive and Sensorineural Hearing Loss Device: super-power BAHA processor

Detailed Description:

The objective of this study is to assess the benefit of new super-power bone-anchored hearing aid (BAHA) processors in BAHA users. BAHAs are able to help people with mixed/conductive and single-sided hearing loss when they were not receiving benefit from traditional hearing aids or could not use them due to differences in their ears related to surgery or congenital anomalies. Stronger super-power processors may be able to help individuals who previously did not meet candidacy for BAHA. This study will evaluate how much benefit they are getting from their current devices compared to new super-power devices.

The information collected in this study may lead to improved evaluation of patients considering BAHA implantation and expanded treatment options for new and existing BAHA users. Primary outcome measures will include hearing threshold and speech perception measures. All devices are commercially available and FDA approved.

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hearing Outcomes Using Super-power Processors in Bone Anchored Implant Recipients
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : April 29, 2017
Actual Study Completion Date : April 29, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort
Hearing and speech tests will be performed on the subject and repeated to compare results obtained using their current BAHA processor against results using super-power BAHA processor.
Device: super-power BAHA processor
The super-power BAHA processor will be provided for use at the study visit only to run different types of hearing tests, speech understanding tests in quiet, and speech understanding tests in noise. The same tests will be performed with the use of the subject's current BAHA processor for comparison.




Primary Outcome Measures :
  1. Threshold testing [ Time Frame: 1 hour ]
    Conventional hearing test will be performed. Sound field testing will be performed to establish aided thresholds using the individual's current BAHA processor and super power BAHA processor

  2. Speech perception in noise [ Time Frame: 1 hour ]
    Speech perception in noise will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processor

  3. Speech perception in quiet [ Time Frame: 1 hour ]
    Word understanding will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult bone-anchored implant recipients who met candidacy criteria for a high gain super-power processor with a fitting range up to 65 dB.
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • meet candidacy criteria for a high gain super-power processor with a fitting range up to 65 dB
  • native English speaker

Exclusion Criteria:

  • do not meet inclusion criteria

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): NCT03118375


Locations
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United States, Florida
University of Miami Department of Otolaryngology
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Hillary Snapp, AuD University of Miami
Publications:
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Responsible Party: Hillary A snapp, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03118375    
Other Study ID Numbers: 20170083
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
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