Super Power in BAI

Terminated

• Conditions: Conductive and Sensorineural Hearing Loss
• Interventions: Device: super-power BAHA processor

• Registration Number: NCT03118375
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-04-12
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-18
• Primary Completion: 2017-04-29
• Study Completion: 2017-04-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

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Exclusion Criteria

• do not meet inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	super-power BAHA processor	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.

Primary Outcome Measures

Name	Time	Method
Speech perception in quiet	1 hour	Word understanding will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processor
Speech perception in noise	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
Threshold testing	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

Trial Locations

Locations (1)

University of Miami Department of Otolaryngology; 🇺🇸 Miami, Florida, United States