NCT07213505

This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.

Investigating New Front-end Features in the SONNET 3

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cochlear implants help individuals with hearing loss by delivering electrical signals directly to the auditory nerve, bypassing damaged parts of the ear. While they significantly improve speech perception in quiet environments and over the telephone, challenges remain in noisy environments due to interference from background noise. To address this, advancements in signal-processing strategies, microphone technology, and noise-reduction algorithms have been introduced. The focus of the study is on two new front-end features: * Focused Beamformer - Enhances directional hearing. * AI Mode Medium - Utilizes the adaptive intelligence for optimized sound processing.

Conditions

• Cochlear Implant Users

Interventions

Type	Name	Description
OTHER	Testing new front-end features	New front-end features (i,e, the Focused Beamformer which nhances directional hearing and the AI Mode Medium (utilizes adaptive intelligence for optimized sound processing) will be compared to the approved beamformer and AI mode) in a within subject design. Subjects will be fitted with a MED-EL SONNET 3 audio processor.

Timeline

• Start date: 2025-09-29
• Primary completion: 2026-09-29
• Completion: 2026-09-29
• First posted: 2025-10-09
• Last updated: 2025-11-21

Locations

2 sites across 1 country: Austria