Investigation of the Automatic Technology on the Naída M Hearing Devices

Completed

• Conditions: Cochlear Hearing Loss
• Interventions: Device: Naida CI M hearing device

• Registration Number: NCT04610216
• Lead Sponsor: Advanced Bionics AG

Brief Summary

In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of the device under investigation on sound perception. This design was shown to be successful in previous studies for the evaluation of sound coding strategies.

Furthermore, a within-subject comparison decreases the variance in the results allowing for fewer subjects when the population using the investigational device is not large in general.

Detailed Description

The primary endpoint of this clinical investigation is the difference in speech intelligibility measured in percent correct with AutoZoomControl compared to an omnidirectional microphone on Naída M hearing devices.The Naída CI M90 sound processor is a behind-the-ear (BTE) sound processor based on the Phonak Marvel hearing aid platform. It replaces the market approved Naída CI Q-Series processors. The Naída Link M90 hearing aid is a behind-the-ear (BTE) hearing aid based on the Phonak Marvel hearing aid platform. It is especially designed to be used for bimodal CI users equipped with a Naída CI M90 sound processor.

Study Timeline

• Study First Submitted: 2020-10-07
• Study Start: 2020-10-20
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-30
• Status Verified: 2021-03
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• · CI users with a CII, HiRes90K (Advantage) or HiRes Ultra (3D) implant system Bilateral users: two implant systems Bimodal users: hearing aid contralateral

  • Minimum of 18 years of age
  • Minimum of six months experience with their implant system
  • Minimum of six months experience with the Naída CI Q-Series sound processor
  • Ability to give feedback on sound quality
  • Speech reception thresholds of no more than 5 dB SNR > 10 at the French Matrix test obtained during previous visits in the clinical routine
  • Fluent in French language

Exclusion Criteria

• Difficulties additional to hearing impairment that would interfere with the study procedures

  • Concurrent participation in other study
  • Incapacity for consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bilateral users: two implant systems	Naida CI M hearing device	For bilateral CI users two Naida CI M sound processors (one per ear) will be used during the study.
Bimodal users: hearing aid contralateral	Naida CI M hearing device	For bimodal subjects there will be one Naida CI M sound processor on the implanted ear as well as one hearing aid on the contralateral ear.

Primary Outcome Measures

Name	Time	Method
Difference in speech intelligibility in noise	2 months	The primary endpoint of this clinical investigation is the difference in speech intelligibility measured in percent correct with AutoZoomControl compared to an omnidirectional microphone on Naída M hearing devices. The French Matrix Test will be used and percentage correct will be recorded.

Secondary Outcome Measures

Name	Time	Method
Differences in speech perception in noise	2 months	ZoomControl versus Omnidirectional microphone and AutoZoomControl versus ZoomControlon Naída M hearing devices will be compared.; The French Matrix Test will be used and percentage correct will be recorded.
Differences in localization abilities	2 months	AutoZoom control versus Omnidirectional microphone, ZoomControl versus Omnidirectional microphone and AutoZoomControl versus ZoomControlon Naída M hearing devices will be compared.; The directions (0,+/-90,180 degrees) from where the sentences of the French Matrix Test are presented have to be determined.; Percentage correct will be recorded.

Trial Locations

Locations (1)

Hôpitaux Universitaires de Genève (HUG); 🇨🇭 Geneva, Switzerland