Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31

NCT ID: NCT03699735

Last Updated: 2019-05-06

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2019-03-29

Brief Summary

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A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements will be carried out. This will be a controlled, single blinded 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

CROSSOVER

Crossover Assignment Each participant will be treated with each test condition in a randomized order.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single (Participant)

Study Groups

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Hearing Aid with beam form principle_A

Device: Hearing Aid beam former principle\_A (simulation of real ear condition). Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.

Group Type ACTIVE_COMPARATOR

Bolero B90-SP

Intervention Type DEVICE

Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss

Hearing Aid with beam form principle_B

Device: Hearing Aid beam former principle\_B. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.

Group Type EXPERIMENTAL

Bolero B90-SP

Intervention Type DEVICE

Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss

Hearing Aid with beam form principle_C

Device: Hearing Aid beam former principle\_C. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.

Group Type EXPERIMENTAL

Bolero B90-SP

Intervention Type DEVICE

Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss

Interventions

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Bolero B90-SP

Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids
* Sensorineural hearing loss (N4-N6 according to ISO 60118-15)
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Informed Consent as documented by signature
* Symmetric hearing loss below 1000 Hz

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 on study site
* Inability to produce a reliable hearing test result
* 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

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_31

Identifier Type: -

Identifier Source: org_study_id

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