Investigation of the Automatic Technology on the Naída M Hearing Devices

Cochlear Hearing Loss Clinical Trial

Official title:

Investigation of the Automatic Technology on the Naída M Hearing Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610216
• Other study ID #: ABIntl-20-15
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Hearing Loss
• Hearing Loss, Sensorineural

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