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

NCT04815343 | Completed

• 1 other identifier: ABIntl-20-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Differences in speech perception in noise threshold measured in Decibel [dB]

  6 weeks

• Differences in speech perception in quiet threshold measured in Decibel [dB]

  6 weeks

• Differences in mono/stereo identification measured in % correct

  6 weeks

• Differences in speech understanding in noise measured in % correct

  6 weeks

• Differences in music enjoyment ratings measured in rating score

  6 weeks

Study Arms (2)

Bilateral users

EXPERIMENTAL

two implant systemswith two sound processors

Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)

Bimodal user

EXPERIMENTAL

with one sound processor and one hearing aid

Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)

Interventions

Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor) DEVICE

Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback

Bilateral users; Bimodal user

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Advanced Bionics AG: lead

Study Sites (1)

Medizinische Hochschule Hannover (MHH)

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: comparision of different conditions with-in subject. (10 bimodal, 10 bilateral CI users)

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 25, 2021
• Study Start: November 20, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 9, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)