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OpenTrials
Completed

NCT Number: NCT05869266

Tuned App Self-Fitting vs. Professional Fitting

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ozen-Kashevet Hearing Clinic

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

professional fitting vs. self fitting

Device

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

Primary outcomes

  1. Comparison of self fitting and professional fitting by COSI scores

    Time frame: 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 outcomes

  1. Comparison of self fitting and professional fitting by IOI-HA scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tuned Ltd.

Industry

Registry information

Official study title

A Prospective, Crossover Randomized Controlled Trial to Compare Subjective Outcome of a Self-fitting Process Using Tuned App to a Licensed Professional Fitting

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 22, 2023
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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