Investigation of the Automatic Technology on the Naída M Hearing Devices

NCT04610216 | Completed

• 1 other identifier: ABIntl-20-15
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Difference in speech intelligibility in noise

  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.

  2 months

Secondary Outcomes (2)

• Differences in speech perception in noise

  2 months

• Differences in localization abilities

  2 months

Study Arms (2)

Bilateral users: two implant systems

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

Device: Naida CI M hearing device

Bimodal users: hearing aid contralateral

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.

Device: Naida CI M hearing device

Interventions

Naida CI M hearing device DEVICE

speech intelligibility measurement with Naida CI M hearing device

Bilateral users: two implant systems; Bimodal users: hearing aid contralateral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• · 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

You may not qualify if:

• Difficulties additional to hearing impairment that would interfere with the study procedures
• Concurrent participation in other study
• Incapacity for consent

Sponsors & Collaborators

• Advanced Bionics AG: lead

Study Sites (1)

Hôpitaux Universitaires de Genève (HUG)

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Angélica Pérez-Fornos, Dr

  angelica.perez-fornos@hcuge.ch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 30, 2020
• Study Start: October 20, 2020
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: May 1, 2024

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)