Investigation of the Automatic Technology on the Naída M Hearing Devices

Advanced Bionics

Status: Completed

Conditions: Cochlear Hearing Loss

Treatments: Device: Naida CI M hearing device

Study type: Observational

Funder types: Industry

Identifiers

NCT04610216

ABIntl-20-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 2 patient groups

Bilateral users: two implant systems

Description:

For bilateral CI users two Naida CI M sound processors (one per ear) will be used during the study.

Treatment:

Device: Naida CI M hearing device

Bimodal users: hearing aid contralateral

Description:

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.

Treatment:

Device: Naida CI M hearing device