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

Cochlear Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04815343
• Other study ID #: ABIntl-20-04
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: August 9, 2021

Study information

• Verified date: November 2021
• Source: Advanced Bionics AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 9, 2021
• Est. primary completion date: May 1, 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 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

Related Conditions & MeSH terms

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

Intervention

Device:
• Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover (MHH)	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 weeks
Secondary	Differences in speech perception in noise threshold measured in Decibel [dB]	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	6 weeks
Secondary	Differences in speech perception in quiet threshold measured in Decibel [dB]	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	6 weeks
Secondary	Differences in mono/stereo identification measured in % correct	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	6 weeks
Secondary	Differences in speech understanding in noise measured in % correct	Differences are compared between AutoZoomControl on Naída M hearing devices and the omnidirectional microphone setting on Naída Q hearing devices	6 weeks
Secondary	Differences in music enjoyment ratings measured in rating score	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	6 weeks