Clinical trial NCT04610216: Investigation of the Automatic Technology on the Naída M Hearing Devices
Official title: Investigation of the Automatic Technology on the Naída M Hearing Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Hearing Loss
Lead sponsor: Advanced Bionics AG
Sponsor class: INDUSTRY
First posted: 2020-10-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intended users of the Naída M hearing system are people who suffer from profound sensorineural hearing losses up to complete deafness. The users could be recipients that are already users of an Advanced Bionics CI but also people who suffer from deafness or profound hearing loss and were not previously equipped with a hearing device. In case of contralateral acoustic hearing, the user might use a Naída CI M90 on the side with profound sensorineural hearing loss and a Naída Link M90 as a hearing aid on the contralateral side to aid the residual acoustic hearing.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in speech intelligibility in noise
timeFrame: 2 months
Secondary outcomes:
measure: Differences in speech perception in noise
timeFrame: 2 months
measure: Differences in localization abilities
timeFrame: 2 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)
Study officials:
affiliation: angelica.perez-fornos@hcuge.ch
name: Angélica Pérez-Fornos, Dr
role: PRINCIPAL_INVESTIGATOR
References: