Investigation of the Automatic Technology on the Naída M Hearing Devices

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.

Study Overview

• Status: Recruiting
• Conditions: Cochlear Hearing Loss
• Intervention / Treatment: Device: Naida CI M hearing device

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 Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Anne Michels, MSc; Phone Number: 78 66 +41 58 928; Email: anne.michels@advancedbionics.com
• Study Contact Backup: Name: Cyrill Reber, MSc; Phone Number: 78 66 +41 58 928; Email: Cyrill.Reber@advancedbionics.com

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • Hôpitaux universitaires de Genève (HUG)
    • Contact: Angélica Pérez-Fornos, PD Dre Sci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; speech intelligibility measurement with 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; speech intelligibility measurement with Naida CI M hearing device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in speech perception in noise	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.	2 months
Differences in localization abilities	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.	2 months

Collaborators and Investigators

• Sponsor: Advanced Bionics AG
• Investigators: Principal Investigator: Angélica Pérez-Fornos, Dr, angelica.perez-fornos@hcuge.ch

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: ABIntl-20-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No