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Completed

NCT Number: NCT04995666

Hearing Aid Quality and Reliability Study

Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.

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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–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova

Aurora, Illinois, 60504, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults with mild to moderate severe sensorineural hearing loss
  • Adults who were able to incorporate some type of physical activity into their day (i.e walking, excercise, gardening, etc.)

Exclusion criteria

  • Unable or unwilling to wear study devices during a home trial
  • Unable or unwilling to come to lab for study visits

Treatment and study plan

Phonak Audeo hearing aid

Device

Rechargeable hearing aid

Primary outcomes

  1. Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1

    Time frame: Day 1 of study

    Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer.

    Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.

  2. Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45

    Time frame: Day 45 of study

    Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).

  3. Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90

    Time frame: Day 90 of study

    Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Official study title

Hearing Aid Quality Check and Reliability Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2021
Registry last updated
May 17, 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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