Investigation of the Automatic Technology on the Naída M Hearing Devices

NCT ID: NCT04610216

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-09-23

Brief Summary

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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

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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.

Conditions

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Cochlear Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bilateral users: two implant systems

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

Naida CI M hearing device

Intervention Type 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.

Naida CI M hearing device

Intervention Type DEVICE

speech intelligibility measurement with Naida CI M hearing device

Interventions

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Naida CI M hearing device

speech intelligibility measurement with Naida CI M hearing device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Bionics AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angélica Pérez-Fornos, Dr

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Hôpitaux Universitaires de Genève (HUG)

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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ABIntl-20-15

Identifier Type: -

Identifier Source: org_study_id

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