Single-Sided Deafness in the Medicare Population
Hearing Loss, UnilateralThe purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
65 and up
Critères de participation
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* External or middle ear infection
* Suspected cognitive concern
* Other medical contraindication for surgery or anesthesia
Lieu de l'étude
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- Med-El Corporation
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05250414