Pre-calculation for Frequency Lowering With Hearing Devices

August 29, 2023 updated by: Sonova AG
Perceptual evaluation of the parametrization and pre-calculation of frequency lowering requires the participation of subjects with hearing loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Kanton Zürich
      • Stäfa, Kanton Zürich, Switzerland, 8712
        • Sonova AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hearing impaired group
The hearing impaired group will compare the reference condition with the intervention condition.
Other: Frequency lowering intervention
Modified parametrization of the current frequency lowering parametrization.
Other Names:
  • Intervention condition
Other: Frequency lowering reference
Current frequency lowering parametrization
Other Names:
  • Reference condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of sound quality and audibility of high-frequency sounds for hearing-impaired subjects with the new parametrization compared to the current implementation of the parametrization.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonova AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2023

Primary Completion (Actual)

April 4, 2023

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 5937

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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