Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus: An Early Feasibility Study
Abstract
The perception of sound when no external noise is present, or tinnitus, affects hundreds of millions of people worldwide. The severity of tinnitus is variable from person to person; however, some develop chronic tinnitus that disrupts everyday life. These patients may experience reduced attention spans, increased distractibility, anxiety, poor sleep, and depression, which may result in significant downstream consequences including diminished quality of life, reduced job performance, and missed work. Unfortunately, no U.S. Food and Drug Administration (FDA)-approved treatment currently exists for patients with bothersome tinnitus. For these reasons, the Fiscal Year 2018 Peer Reviewed Medical Research Program identified Tinnitus as a Congressionally directed Topic Area. The current study addresses the Tinnitus Area of Encouragement regarding the identification and development of novel devices to treat tinnitus. In this way, the primary objective of the current study is to evaluate the safety and efficacy of a novel Tinnitus Implant System modeled after the widely successful cochlear implant. The knowledge and technology gained from this research will have the capacity to benefit the civilian population and simultaneously address a significant military need. Past research showed that cochlear implantation improves tinnitus in patients with advanced hearing loss. However, cochlear implantation often results in loss of most, if not all, natural hearing. Therefore, the majority of patients with tinnitus do not qualify for cochlear implantation because they have normal hearing or only moderate hearing loss. Our research specifically targets this large patient group for whom no effective long-term treatment exists. Our study will enroll 12 adults who have chronic severe tinnitus and normal hearing to moderate hearing loss to receive the first tinnitus implant systems. This novel device will provide similar tinnitus-suppressing effects to that of a cochlear implant, without causing hearing loss. Subjects will be followed over the course of 1 year with frequent doctor visits while assessing their tinnitus over time by answering tinnitus severity questionnaires.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Nov 19, 2019
- Source ID
- W81XWH1910021
Entities
People
- Matthew Carlson
Organizations
- Mayo Clinic
- United States Army