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Pre-calculation for Frequency Lowering With Hearing Devices

Sponsor
Sonova AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05733169
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
3.4
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Frequency lowering intervention
  • Other: Frequency lowering reference
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pre-calculation for Frequency Lowering With Hearing Devices
Actual Study Start Date :
Jan 16, 2023
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sonova AG Stäfa Kanton Zürich Switzerland 8712

    Sponsors and Collaborators

    • Sonova AG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sonova AG
    ClinicalTrials.gov Identifier:
    NCT05733169
    Other Study ID Numbers:
    • 5937
    First Posted:
    Feb 17, 2023
    Last Update Posted:
    Feb 17, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 17, 2023