Exploration of the Functional Effect of Different Hearing Aid Noise Reduction Algorithms in an Ecologically Valid Conversational Situation

NCT ID: NCT06992310

Last Updated: 2025-06-03

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-09-30

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 novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements as well as subjective ratings 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 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 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

Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 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 to mimic the natural directivity of the outer ear.

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 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 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 experimental conditions 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 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 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 experimental conditions vary in their parametrization 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)

Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 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 to mimic the natural directivity of the outer ear.

Intervention Type DEVICE

Hearing Aid with NR_2

Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 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 experimental conditions 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 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 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 experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Good written and spoken German language skills
* No suffering from any speech disorders
* Experienced hearing aid user (min. 6 months)
* Ability to stand and walk during the experiment
* Ability to fill in a questionnaire conscientiously
* Ability to produce a reliable hearing test result
* Ability to describe listening experiences/impressions
* The audiogram is in the fitting range of the hearing aid
* The audiogram is in the range of mild to moderate hearing losses (N2 - N4)
* Hearing loss in both ears
* Informed consent form

Exclusion Criteria

* Contraindications to the medical device
* Unaidable hearing loss in one or both ears
* Acute tinnitus (in either one ear and occurrence for less than 3 months)
* Anatomical deformity of one or both ears
* Single-sided deafness
* Unwillingness to wear the investigational device during the investigational visits
* Active pacemaker implant
* Ear canals are too narrow to take ear impressions
* Ear canals are too narrow for the use of customized earpieces
* Uncomfortable loudness threshold less than 80 dB for at least one measured frequency
* Known hypersensitivity or allergy against synthetic materials
* Acute symptoms of vertigo or dizziness
* Reported Parkinson's disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sebastian Griepentrog

INDUSTRY

Sponsor Role lead

Responsible Party

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Sebastian Griepentrog

Clinical studies manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Josephine Hollenbach

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Locations

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Sonova AG

Stäfa, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Sebastian Griepentrog

Role: CONTACT

004158928 ext. 8676

Facility Contacts

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Sebastian Griepentrog

Role: primary

004158928 ext. 8676

Other Identifiers

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SRF-30177

Identifier Type: -

Identifier Source: org_study_id

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