The use of hearing aids with an integrated noise generator to the tinnitus control

• Grant number: 11/03001-2
• Support Opportunities: Regular Research Grants
• Start date: March 01, 2012
• End date: February 28, 2014
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Ricardo Ferreira Bento
• Grantee: Ricardo Ferreira Bento
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated researchers: Gisele Munhoes dos Santos Ferrari

Abstract

The association between tinnitus and hearing loss is well established in the literature. It is suggested that 90% of tinnitus patients also show some degree of hearing loss. The two symptoms can have significant repercussion on the daily life of patients, due both to the discomfort caused by the tinnitus and to the communicative limitations resulting from the hearing loss. Acoustic stimulation by hearing aid is considered a vital component of any tinnitus control program since their goal is to increase the level of environmental sound and reduce tinnitus perception. When conventional hearing aids are not able to mask the tinnitus, they are replaced with combined instruments (hearing aid + sound generator). According to some authors, these increase success and significantly reduce distress caused by tinnitus. The University of São Paulo Faculty of Medicine's department of otorhinolaryngology developed the Manaus model of digital technology acoustic hearing aid (FAPESP process 2007/04788-0) publicized in the academic and lay media. Based on this positive experience, researchers have developed prototypes for an also digital new hearing aid but with an inbuilt sound generator. These prototypes assist both hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the population). Currently, the SUS (Unified Health System - Brazilian public heath care) does not have any such hearing aids to carry out Public Policies (Decree 587, Addendum IV, May 2004). In that sense 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 assess the efficacy of the hearing aid with an integrated sound generator 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.A sample of 70 patients with tinnitus associated hearing loss will be randomly distributed into two groups. Group A will be bilaterally fitted with the Sabará hearing aid with sound generator turned on. Group B will be bilaterally fitted with the same hearing aid with sound generator turned off. The Sabará is a hearing aid with an integrated sound generator for the treatment of tinnitus that is currently under research in the University of São Paulo Faculty of Medicine. Patients' participation in the study will be voluntary and confirmed by the signature of the Free and Informed Consent Form. Both groups will receive specific directions on tinnitus and will have their hearing and degree of tinnitus discomfort reevaluated after 3, 6 and 12 months of hearing aid use. In the reevaluations, the research on the tinnitus discomfort, main result to be measured, will be assessed by a blind-evaluator and the outcome will be quantified in the 12th month. (AU)