Single-Sided Deafness in the Medicare Population

MED-EL

Status: Enrolling

Conditions: Hearing Loss, Unilateral

Treatments: Device: MED-EL Cochlear Implant System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05250414

MED-EL SSD CMS

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.

Full description

The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will recruit subjects into this study. Study subjects will be followed for 12 months post-implantation of the device.

Enrollment: 15 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Study Procedure

Other group

Treatment:

Device: MED-EL Cochlear Implant System