The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial

Study Overview
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Brief Summary
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The University of Sao Paulo Department of Otorhinolaryngology developed prototypes for a digital new hearing aid with an integrated sound generator. These prototypes assist both hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the population). Currently, the Brazilian Public Heath Care does not have any such hearing aids. So, the development of devices for the hearing rehabilitation as well as the treatment of tinnitus represents an advance in the implementation of Public Policies in Brazil. The aim of this study is to compare the efficacy of the hearing aid with an integrated sound generator and amplification alone for tinnitus control in patients with tinnitus associated hearing loss.

Detailed Description
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This study, in the form of a blind randomized clinical trial, was approved by CAPPesq under protocol number: 0163/10. 49 adults with tinnitus and sensorineural hearing loss were randomly assigned into 2 groups. Both groups received counseling about tinnitus. One group received hearing aids with only amplification and the other group received hearing aids with an integrated sound generator. After the fitting process, both groups were told to use the hearing devices 8 hours per day. The outcome measures as the tinnitus handicap inventory and psychoacoustics measurements were conducted by a blind audiologist that didn't know each group each patient belonged to.

Official Title
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The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial

Conditions
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Tinnitus, Hearing Loss

Intervention / Treatment
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* Device: sound generator
* Device: hearing aids with only amplification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild to moderate sensorineural hearing loss tinnitus (THI > 20) first user Exclusion Criteria: profound hearing loss conductive hearing loss THI < 20

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control<br>hearing aid without an integrated sound generator | Device: hearing aids with only amplification<br> <br> |
| Experimental: sound generator<br>hearing aid with an integrated sound generator | Device: sound generator<br>* hearing aid with an integrated sound generator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| THI | tinnitus handicap inventory | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, hearing loss, hearing devices