NCT03118375

Super Power in BAI

Hearing Outcomes Using Super-power Processors in Bone Anchored Implant Recipients

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Conductive and Sensorineural Hearing Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-04-12
• Primary completion: 2017-04-29
• Completion: 2017-04-29
• First posted: 2017-04-18
• Last updated: 2023-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study