Single-Sided Deafness in the Medicare Population
A legfontosabb adatok
- Hol
- Chapel Hill és Iowa City (Egyesült Államok)Mind a 2 helyszín megnézése
Helyszínek itt: Egyesült Államok
- University of North CarolinaChapel Hill, Egyesült ÁllamokNo longer taking part
- University of Iowa Hospitals and ClinicsIowa City, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Med-El Corporation
- Azonosító
- NCT05250414
- A regiszteradat frissítve
- 2026. augusztus 31.
- Eredeti leírás
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.A teljes eredeti leírásKevesebb
Cochlear Implantation in the Single-Sided Deafness in the Medicare Population
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
Bevonási feltételek: 65 years of age or older at the time of implantation; Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted; Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz; Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less; Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet; Previous experience with an appropriately-fit CROS, BI-CROS, bone conduction, or traditional hearing aid, as deemed appropriate by investigator; Fluent in English.
Kizáró feltételek: Other medical contraindication for surgery or anesthesia; External or middle ear infection; Duration of profound hearing loss of 10 years or more; Sudden onset of hearing loss within six months of implantation; Evidence of non-functional cochlear nerve or other retrocochlear hearing loss; Evidence of severe cochlear malformation (i.e., common cavity or ossification); Suspected cognitive concern.