Hearing Loss Clinical Trial
Official title:
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
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.
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.
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