Super Power in BAI
|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
|Condition or disease||Intervention/treatment|
|Conductive and Sensorineural Hearing Loss||Device: super-power BAHA processor|
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.
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|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|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118375
|United States, Florida|
|University of Miami Department of Otolaryngology|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Hillary Snapp, AuD||University of Miami|