Clinical Trial: Super Power in BAI

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

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

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 Summary:

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.

Sponsor: University of Miami

Current Primary Outcome:

• 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
• 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
• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Miami

Dates:
Date Received: April 12, 2017
Date Started: April 12, 2017
Date Completion: December 15, 2017
Last Updated: April 20, 2017
Last Verified: April 2017