Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

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

2018-12-03

Study Completion Date

2019-03-15

Brief Summary

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A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired. These sound changing principles are enabled by respective hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.

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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

Each participant will be treated with sound principle 1, 2 and 3 in a crossover design.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The participant's will not know which intervention will be applied.

Study Groups

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Sound Processing Principle 1

Sound Processing Principle 1 will be applied in the hearing aid.

Group Type ACTIVE_COMPARATOR

Phonak Audéo L2M with Sound Processing Principle 1

Intervention Type DEVICE

Compensation of a hearing loss with Sound Processing Principle 1.

Sound Processing Principle 2

Sound Processing Principle 2 will be applied in the hearing aid.

Group Type EXPERIMENTAL

Phonak Audéo L2M with Sound Processing Principle 2

Intervention Type DEVICE

Compensation of a hearing loss with Sound Processing Principle 2.

Sound Processing Principle 3

Sound Processing Principle 3 will be applied in the hearing aid.

Group Type EXPERIMENTAL

Phonak Audéo L2M with Sound Processing Principle 3

Intervention Type DEVICE

Compensation of a hearing loss with Sound Processing Principle 3.

Interventions

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Phonak Audéo L2M with Sound Processing Principle 1

Compensation of a hearing loss with Sound Processing Principle 1.

Intervention Type DEVICE

Phonak Audéo L2M with Sound Processing Principle 2

Compensation of a hearing loss with Sound Processing Principle 2.

Intervention Type DEVICE

Phonak Audéo L2M with Sound Processing Principle 3

Compensation of a hearing loss with Sound Processing Principle 3.

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 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
* Known central hearing disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No