Cochlear Hearing Loss Clinical Trial
Official title:
Investigation of the Automatic Technology on the Naída M Hearing Devices
Verified date | March 2021 |
Source | Advanced Bionics AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Hôpitaux Universitaires de Genève (HUG) | Geneva |
Lead Sponsor | Collaborator |
---|---|
Advanced Bionics AG |
Switzerland,
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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