Pre-calculation for Frequency Lowering With Hearing Devices

NCT ID: NCT05733169

Last Updated: 2023-08-30

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2023-04-04

Brief Summary

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Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss.

Detailed Description

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Conditions

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Frequency Lowering

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hearing impaired group

The hearing impaired group will compare the reference condition with the intervention condition.

Group Type EXPERIMENTAL

Frequency lowering intervention

Intervention Type OTHER

Modified parametrization of the current frequency lowering parametrization.

Frequency lowering reference

Intervention Type OTHER

Current frequency lowering parametrization

Interventions

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Frequency lowering intervention

Modified parametrization of the current frequency lowering parametrization.

Intervention Type OTHER

Frequency lowering reference

Current frequency lowering parametrization

Intervention Type OTHER

Other Intervention Names

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Intervention condition Reference condition

Eligibility Criteria

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Inclusion Criteria

* Experienced hearing aid user (minimum use duration 1 year)
* Adult (minimum age: 18 years),
* Experience with frequency lowering,
* Hearing thresholds with N5-N7, S1, S2, S3 hearing loss
* Symmetrical hearing loss (difference between ears \<= 10 dB for 1kHz-6kHz) ,
* Sensorineural hearing loss,
* Air Conduction - bone conduction gap \<= 10 dB,
* Written and spoken German,
* Ability to understand instruction,
* Ability to describe listening experiences,
* Ability to attend to the appointments,
* Ability to fill in a questionnaire conscientiously
* Healthy outer ear (without previous surgical procedures)
* Hearing loss within the fitting ranges of the investigational product,
* Informed consent as documented by signature.

Exclusion Criteria

* Clinical contraindications deformity of the ear (closed ear canal
* or absence of pinna),
* Not willing to wear the hearing aid,
* Fluctuating hearing that could influence the results,
* Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product,
* Limited mobility and not in the position to attend all appoint-ments,
* 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

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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5937

Identifier Type: -

Identifier Source: org_study_id

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