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Quality Control of CE-Certified Phonak Hearing Aids - 2017_27

NCT ID: NCT03253003

Last Updated: 2017-09-25

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2017-08-25

Brief Summary

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A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.

Detailed Description

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Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Conditions

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Hearing Loss, Bilateral Sensorineural, Progressive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Audéo B hearing aid line extension

The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Group Type EXPERIMENTAL

Line extension of the Phonak Audéo B product family

Intervention Type DEVICE

The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Interventions

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Line extension of the Phonak Audéo B product family

The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature
* Smartphone user

Exclusion Criteria

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* 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

Maximum Eligible Age

99 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 of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Sonova2017_27

Identifier Type: -

Identifier Source: org_study_id