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

U

University of Sao Paulo

Status

Completed

Conditions

Hearing Loss
Tinnitus

Treatments

Device: hearing aids with only amplification
Device: sound generator

Study type

Interventional

Funder types

Other

Identifiers

NCT01857661
2011/03001-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

49 participants in 2 patient groups

control
Other group
Description:
hearing aid without an integrated sound generator
Treatment:
Device: hearing aids with only amplification
sound generator
Experimental group
Description:
hearing aid with an integrated sound generator
Treatment:
Device: sound generator

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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