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

Not Applicable

Completed

• Conditions: Tinnitus; Hearing Loss
• Interventions: Device: hearing aids with only amplification; Device: sound generator

• Registration Number: NCT01857661
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-20
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• mild to moderate sensorineural hearing loss
• tinnitus (THI > 20)
• first user

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Exclusion Criteria

• profound hearing loss
• conductive hearing loss
• THI < 20

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	hearing aids with only amplification	hearing aid without an integrated sound generator
sound generator	sound generator	hearing aid with an integrated sound generator

Primary Outcome Measures

Name	Time	Method
THI	3 months	tinnitus handicap inventory