Conductive and Sensorineural Hearing Loss Clinical Trial
Official title:
Hearing Outcomes Using Super-power Processors in Bone Anchored Implant Recipients
| NCT number | NCT03118375 |
| Other study ID # | 20170083 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 12, 2017 |
| Est. completion date | April 29, 2017 |
| Verified date | April 2023 |
| Source | University of Miami |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | April 29, 2017 |
| Est. primary completion date | April 29, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Miami Department of Otolaryngology | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Miami |
United States,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Threshold testing | 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 | 1 hour | |
| Primary | Speech perception in noise | Speech perception in noise will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processor | 1 hour | |
| Primary | Speech perception in quiet | Word understanding will be evaluated without hearing devices and then using the individual's current BAHA processor and super power BAHA processor | 1 hour |