Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios

Advanced Bionics

Status

Completed

Conditions

Cochlear Hearing Loss

Treatments

Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04815343

ABIntl-20-04

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 Naída Link M90 hearing aid and Naída CI M90 sound processor 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 that uses the investigational device is not large in general.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

CI users with a CII, HiRes90K (Advantage) or HiRes Ultra 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 intelligibility with the HSM sentence test in noise at 10 dB SNR > 10% as obtained during previous visits in the clinical routine
Fluent in German language

Exclusion criteria

Difficulties additional to hearing impairment that would interfere with the study procedures
Concurrent participation in other study
Pregnant and breast-feeding women