Evaluation of Novel Noise Reduction Principles in Hearing Instruments

NCT ID: NCT05582408

Last Updated: 2022-11-17

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2022-11-01

Brief Summary

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In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Hearing Aid Standard NR1

Hearing Aid with standard Noise Reduction (NR1) serves as reference condition.

Group Type ACTIVE_COMPARATOR

Measures of Standard Noise Reduction NR1

Intervention Type DEVICE

Each participant will be fitted with the Standard Noise Reduction (NR1)

Novel Noise reduction principles

Noise Reduction Principle NR2 and NR3.

Group Type EXPERIMENTAL

Measures of Noise Reduction Principle NR2

Intervention Type DEVICE

Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid

Measure of Noise Reduction Principle NR3

Intervention Type DEVICE

Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid

Interventions

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Measures of Standard Noise Reduction NR1

Each participant will be fitted with the Standard Noise Reduction (NR1)

Intervention Type DEVICE

Measures of Noise Reduction Principle NR2

Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid

Intervention Type DEVICE

Measure of Noise Reduction Principle NR3

Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users,
* Written and spoken German,
* Hearing loss range: N3-N4 Hearing loss (sensorineural)
* Healthy outer ear,
* Ability to understand and follow the instruction of the in-vestigator
* Informed consent as documented by signature.

Exclusion Criteria

* Clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve
* Pregnant or breastfeeding women
* Age \>85 years
* known hypersensitivity or allergy,
* limited mobility and not able to attend the appointments
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 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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Marlene Zippel

Role: STUDY_DIRECTOR

Sonova AG

Locations

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Hörzentrum Oldenburg gGmbH

Oldenburg, Lower Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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SRF-382

Identifier Type: -

Identifier Source: org_study_id

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