Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)

NCT ID: NCT02754843

Last Updated: 2016-04-28

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Brief Summary

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The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Naida Q90-SP

Phonak's commercial power Behind-The-Ear (BTE) device, type 1.

Group Type ACTIVE_COMPARATOR

Phonak's equivalent newly developped power BTE

Intervention Type DEVICE

Equivalent competitor device

Intervention Type DEVICE

Naida Q90-UP

Phonak's commercial power Behind-The-Ear (BTE) device, type 2.

Group Type ACTIVE_COMPARATOR

Phonak's equivalent newly developped power BTE

Intervention Type DEVICE

Equivalent competitor device

Intervention Type DEVICE

Interventions

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Phonak's equivalent newly developped power BTE

Intervention Type DEVICE

Equivalent competitor device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hearing impaired persons with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria

* Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simone Ebbing, B.Sc.

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Locations

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Sonova AG

Stäfa, Canton Zürich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Sonova2015-00

Identifier Type: -

Identifier Source: org_study_id

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