Trials / Completed
CompletedNCT01857661
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- University of Sao Paulo · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | sound generator | hearing aid with an integrated sound generator |
| DEVICE | hearing aids with only amplification |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2013-05-20
- Last updated
- 2013-06-26
Source: ClinicalTrials.gov record NCT01857661. Inclusion in this directory is not an endorsement.