Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios

Not Applicable

Completed

• Conditions: Cochlear Hearing Loss
• Interventions: Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)

• Registration Number: NCT04815343
• Lead Sponsor: Advanced Bionics AG

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 Naída Link M90 hearing aid and Naída CI M90 sound processor 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 that uses the investigational device is not large in general.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-20
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-25
• Primary Completion: 2021-05-01
• Study Completion: 2021-08-09
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• CI users with a CII, HiRes90K (Advantage) or HiRes Ultra 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 intelligibility with the HSM sentence test in noise at 10 dB SNR > 10% as obtained during previous visits in the clinical routine

• Fluent in German language

Exclusion Criteria

• Difficulties additional to hearing impairment that would interfere with the study procedures
• Concurrent participation in other study
• Pregnant and breast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral users	Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)	two implant systemswith two sound processors
Bimodal user	Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)	with one sound processor and one hearing aid

Primary Outcome Measures

Name	Time	Method
Difference in speech perception in noise with AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices	6 weeks	Difference in speech reception threshold of 50% speech understanding which is the signal to noise ratio in Decibel \[dB\] to understand 50% of the target speech between AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices.

Secondary Outcome Measures

Name	Time	Method
Differences in speech perception in noise threshold measured in Decibel [dB]	6 weeks	Differences are compared between AutoSense OS on Naída M hearing devices and the omnidirectional microphone setting on Naída Q hearing devices.; Min and Max values are -10dB and +10dB, whereas the smalller the value the better
Differences in speech understanding in noise measured in % correct	6 weeks	Differences are compared between AutoZoomControl on Naída M hearing devices and the omnidirectional microphone setting on Naída Q hearing devices
Differences in music enjoyment ratings measured in rating score	6 weeks	Differences are compared between; * mono and stereo free-field presentation; * mono and stereo streaming presentation; * stereo free-field and stereo streaming presentation; * mono free-field and mono streaming presentation
Differences in speech perception in quiet threshold measured in Decibel [dB]	6 weeks	Differences are compared between AutoSense OS on Naída M hearing devices and AutoSound OS on Naída Q hearing devices and the omnidirectional microphone setting on Naída Q hearing devices.; Min and Max values are -10dB and +10dB, whereas the smalller the value the better
Differences in mono/stereo identification measured in % correct	6 weeks	Differences are compared between mono and stereo free-field presentation, mono and stereo streaming presentation, stereo free-field and stereo streaming presentation, mono free-field and mono streaming presentation, differences in music enjoyment ratings measured in rating score

Trial Locations

Locations (1)

Medizinische Hochschule Hannover (MHH); 🇩🇪 Hannover, Niedersachsen, Germany