Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application - Sonova2018_34

NCT ID: NCT03755453

Last Updated: 2019-05-09

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-11

Study Completion Date

2019-02-28

Brief Summary

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A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled and randomised active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

All participants will receive a hearing aid fitted with fitting method A and afterwards fitted with fitting method B.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Audéo B-Direct fitted with fitting method A

Traditional standard fitting method which do not include adjustments from the participants.

Group Type ACTIVE_COMPARATOR

Hearing aid: Phonak Audéo B90-Direct

Intervention Type DEVICE

Hearing aids will be fitted to the participants individual hearing loss.

Audéo B-Direct fitted with fitting method B

Alternative fitting method which includes additional adjustments from the participants.

Group Type EXPERIMENTAL

Hearing aid: Phonak Audéo B90-Direct

Intervention Type DEVICE

Hearing aids will be fitted to the participants individual hearing loss.

Interventions

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Hearing aid: Phonak Audéo B90-Direct

Hearing aids 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
* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

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 appointments
* Limited ability to describe listening impressions or to use hearing aids/ accessories
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known 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

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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Sonova2018_34

Identifier Type: -

Identifier Source: org_study_id

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