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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04610216
Other study ID # ABIntl-20-15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 20, 2020
Est. completion date September 23, 2021

Study information

Verified date March 2021
Source Advanced Bionics AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 23, 2021
Est. primary completion date September 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Naida CI M hearing device
speech intelligibility measurement with Naida CI M hearing device

Locations

Country Name City State
Switzerland Hôpitaux Universitaires de Genève (HUG) Geneva

Sponsors (1)

Lead Sponsor Collaborator
Advanced Bionics AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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