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

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.

Study Overview

• Status: Completed
• Conditions: Cochlear Hearing Loss
• Intervention / Treatment: Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover (MHH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral users; two implant systemswith two sound processors	Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor); Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback
Experimental: Bimodal user; with one sound processor and one hearing aid	Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor); Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Advanced Bionics AG

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): August 9, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: ABIntl-20-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No