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

NCT ID: NCT04815343

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-08-09

Brief Summary

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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

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Conditions

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Cochlear Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

comparision of different conditions with-in subject. (10 bimodal, 10 bilateral CI users)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Bilateral users

two implant systemswith two sound processors

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Bimodal user

with one sound processor and one hearing aid

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Bionics AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medizinische Hochschule Hannover (MHH)

Hanover, Lower Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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ABIntl-20-04

Identifier Type: -

Identifier Source: org_study_id