NCT03236909

Expanded Indications in the Adult Cochlear Implant Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Med-El Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.

Detailed description

Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. . Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DEVICE	MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System	Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.

Timeline

• Start date: 2018-04-16
• Primary completion: 2023-03-27
• Completion: 2023-03-27
• First posted: 2017-08-02
• Last updated: 2025-06-24
• Results posted: 2025-06-24

Locations

5 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study