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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Other | hearing aid without an integrated sound generator |
|
| sound generator | Experimental | hearing aid with an integrated sound generator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sound generator | Device | hearing aid with an integrated sound generator |
| |
| Measure | Description | Time Frame |
|---|---|---|
| THI | tinnitus handicap inventory | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25073131 | Derived | dos Santos GM, Bento RF, de Medeiros IR, Oiticcica J, da Silva EC, Penteado S. The influence of sound generator associated with conventional amplification for tinnitus control: randomized blind clinical trial. Trends Hear. 2014 Jul 23;18:2331216514542657. doi: 10.1177/2331216514542657. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 20, 2014 | |
| Reset | Jun 19, 2014 | |
| Release | Jun 24, 2014 | |
| Reset | Jul 19, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2014 | Jun 19, 2014 | |||
| Jun 24, 2014 |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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| hearing aids with only amplification |
| Device |
|
| Jul 19, 2014 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |