Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_20

NCT ID: NCT04018911

Last Updated: 2019-10-11

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2019-09-16

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 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 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 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

Each participant will be treated with each sound changing principle (Noise Reduction principle (NR)) in a randomized order.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hearing Aid standard NR_1

Hearing Aid with standard Noise Reduction (NR) serves as reference condition.

Group Type ACTIVE_COMPARATOR

Hearing Aid with standard Noise Reduction (NR_1)

Intervention Type DEVICE

Hearing Aid with standard Noise Reduction (NR) Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle.

Hearing Aid with NR_2

NR\_2: Noise Reduction principle 2

Group Type EXPERIMENTAL

Hearing Aid with NR_2

Intervention Type DEVICE

Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.

Hearing Aid with NR_3

NR\_3: Noise Reduction principle 3

Group Type EXPERIMENTAL

Hearing Aid with NR_3

Intervention Type DEVICE

Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.

Hearing Aid with NR_4

NR\_4: Noise Reduction principle 4

Group Type EXPERIMENTAL

Hearing Aid with NR_4

Intervention Type DRUG

Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. This experimental condition combines standard NR and novel NR principle to result in different degrees of noise suppression and good speech quality.

Interventions

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Hearing Aid with standard Noise Reduction (NR_1)

Hearing Aid with standard Noise Reduction (NR) Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle.

Intervention Type DEVICE

Hearing Aid with NR_2

Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.

Intervention Type DEVICE

Hearing Aid with NR_3

Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.

Intervention Type DEVICE

Hearing Aid with NR_4

Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. This experimental condition combines standard NR and novel NR principle to result in different degrees of noise suppression and good speech quality.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 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
* 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
* colour blinded
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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Juliane Raether

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Locations

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Sonova AG

Stäfa, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Sonova2019_20

Identifier Type: -

Identifier Source: org_study_id

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