Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 4:15 PM
Study NCT ID:
NCT01857661
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2013-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: