Investigation of the Automatic Technology on the Naída M Hearing Devices

Sponsor

Advanced Bionics AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04610216

Collaborator

(none)

Enrollment

Location

12.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cochlear Hearing Loss	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 Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Investigation of the Automatic Technology on the Naída M Hearing Devices

Actual Study Start Date :

Oct 20, 2020

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Difference in speech intelligibility in noise [2 months]
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.

Secondary Outcome Measures

Differences in speech perception in noise [2 months]
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.
Differences in localization abilities [2 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpitaux Universitaires de Genève (HUG)	Geneva		Switzerland	1211

Sponsors and Collaborators

Advanced Bionics AG

Investigators

Principal Investigator: Angélica Pérez-Fornos, Dr, angelica.perez-fornos@hcuge.ch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Advanced Bionics AG

ClinicalTrials.gov Identifier:

NCT04610216

Other Study ID Numbers:

ABIntl-20-15

First Posted:

Oct 30, 2020

Last Update Posted:

Mar 19, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hearing Loss

Hearing Loss, Sensorineural

Study Results

No Results Posted as of Mar 19, 2021