Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16

NCT ID: NCT03578471

Last Updated: 2018-09-18

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2018-07-31

Brief Summary

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An EEG study using continuous speech stimuli to assess neural language processing in a hearing impaired population. Participants listen to short radio excerpts in different Signal to Noise Ratios (SNR) and answer comprehension questions as well as listening effort questions. We assess the effect of different algorithms on neural language processing as well as subjective listening effort. Each participant hears 12 randomized segments of speech (about 4min long each) with different settings on their hearing aid (reference condition, noise reduction algorithm, beam forming algorithm). 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 Stäfa.

Detailed Description

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Conditions

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Hearing Loss Normal Hearing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hearing Aid without NR and BF

Hearing Aid without Noise Reduction (NR) or beam forming (BF) enabled serves as reference condition.

Group Type ACTIVE_COMPARATOR

Hearing Aid without NR and BF

Intervention Type DEVICE

Each participant will be fitted with the Noise Reduction (NR) and Beamforming (BF) disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.

Hearing Aid with NR

Hearing Aid with Noise Reduction (NR) enabled.

Group Type EXPERIMENTAL

Hearing Aid with NR

Intervention Type DEVICE

Each participant will be fitted with the Noise Reduction (NR)(Sound Changing) program on the same hearing aid. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The Noise Reduction is working spatially independent.

Hearing Aid with BF

Hearing Aid with beam forming (BF) enabled.

Group Type EXPERIMENTAL

Hearing Aid with BF

Intervention Type DEVICE

Each participant will be fitted with a beam forming program on the same hearing aid. Beam forming (BF) principle is a sound processing algorithm to remove noise from certain directions to improve the speech intelligibility and comfort.

Interventions

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Hearing Aid without NR and BF

Each participant will be fitted with the Noise Reduction (NR) and Beamforming (BF) disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.

Intervention Type DEVICE

Hearing Aid with NR

Each participant will be fitted with the Noise Reduction (NR)(Sound Changing) program on the same hearing aid. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The Noise Reduction is working spatially independent.

Intervention Type DEVICE

Hearing Aid with BF

Each participant will be fitted with a beam forming program on the same hearing aid. Beam forming (BF) principle is a sound processing algorithm to remove noise from certain directions to improve the speech intelligibility and comfort.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Sonova2018_16

Identifier Type: -

Identifier Source: org_study_id

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