Super Power in BAI

University of Miami

Status: Terminated

Conditions: Conductive and Sensorineural Hearing Loss

Treatments: Device: super-power BAHA processor

Study type: Observational

Funder types: Other

Identifiers

NCT03118375

20170083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 1 patient group

Cohort

Description:

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.

Treatment:

Device: super-power BAHA processor