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Tuned App Self-Fitting vs. Professional Fitting

Sponsor
Tuned Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05869266
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
2
Anticipated Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to compare the perceived outcome of the self-fitting performed by the participants using the Tuned mobile application with the traditional professional fitting as performed by a licensed professional audiologist in subjects with mild to moderate sensorineural hearing loss.

Condition or Disease Intervention/Treatment Phase
  • Device: professional fitting vs. self fitting
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Prospective, randomized crossover clinical study comparing two methods of fitting subjects with mild to moderate sensorineural hearing loss with hearing aids. Subjects will receive hearing aids and be assigned to professional-fitting arm or self-fitting arm, use the hearing aids for two weeks then switch to the other arm and use the hearing aids for another two weeks.Prospective, randomized crossover clinical study comparing two methods of fitting subjects with mild to moderate sensorineural hearing loss with hearing aids. Subjects will receive hearing aids and be assigned to professional-fitting arm or self-fitting arm, use the hearing aids for two weeks then switch to the other arm and use the hearing aids for another two weeks.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Prospective, Crossover Randomized Controlled Trial to Compare Subjective Outcome of a Self-fitting Process Using Tuned App to a Licensed Professional Fitting
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Professional-fitting

Subject receives hearing aids and a licensed professional performs the hearing aid fitting using professional programing tools, and the thresholds that were obtained from the traditional audiometry. Subject uses the professionally fitted hearing aids for two weeks then completes COSI and the IOI-HA questionnaires.

Device: professional fitting vs. self fitting
Licensed professional fits the hearing aid fitting using professional programing tools and thresholds obtained from the traditional audiometry vs. subject performs self-fitting of the hearing aids using the Tuned App.
Other Names:
  • Tuned App

    		•
    Active Comparator: Self-fitting

    Subject receives hearing aids, downloads the Tuned self fitting App and performs self-fitting of the hearing aids including a self-hearing test. Subject uses the self fitted hearing aids for two weeks then completes COSI and the IOI-HA questionnaires.

    Device: professional fitting vs. self fitting
    Licensed professional fits the hearing aid fitting using professional programing tools and thresholds obtained from the traditional audiometry vs. subject performs self-fitting of the hearing aids using the Tuned App.
    Other Names:
  • Tuned App

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of self fitting and professional fitting by COSI scores [4 weeks]

      To compare the professional fitting and the self fitting using the Tuned App, the scores of Client Oriented Scale of Improvement (COSI) questionnaire will be used.

    Secondary Outcome Measures

    1. Comparison of self fitting and professional fitting by IOI-HA scores [4 weeks]

      To compare the subjects' self-reported outcomes between professional fitting and self fitting using the Tuned App, the scores of the International Outcome Inventory for Hearing Aids (IOI-HA) questionnaires will be used.

    Eligibility Criteria

    Criteria

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

    • Adult males and females, 18 years and older.

    • Mild to moderate sensorineural hearing loss.

    • Own and able to use a smart phone (Android or iOS).

    • Able to read and understand Hebrew.

    Exclusion Criteria:

    • Conductive mixed hearing loss.

    • Unilateral hearing loss.

    • Any external or inner ear malformations.

    • Symptoms of ear disease or excessive cerumen.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ozen-Kashevet Hearing Clinic Jerusalem Israel

    Sponsors and Collaborators

    • Tuned Ltd.

    Investigators

    • Principal Investigator: Leonid Kriksunov, Ozen-Kashevet Hearing Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tuned Ltd.
    ClinicalTrials.gov Identifier:
    NCT05869266
    Other Study ID Numbers:
    • TU1-PLN-111
    First Posted:
    May 22, 2023
    Last Update Posted:
    May 23, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Tuned Ltd.
    self fitting
    Additional relevant MeSH terms:
    Hearing Loss
    Seizures

    Study Results

    No Results Posted as of May 23, 2023