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OpenTrials
Completed

NCT Number: NCT05612763

Self Fitting Hearing Aid Clinical Investigation

Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss 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

Starkey Laboratories

Eden Prairie, Minnesota, 55344, United States

About this study

The purpose of this study is to evaluate the outcomes of hearing aids with patient-driven fitting (PD) and clinician-driven fitting (CD). The participants will be 40 adults with mild to moderate symmetrical hearing loss. For each hearing aid fitting strategy, the participant will wear the hearing aids for 10 days. Lab and field outcomes will be measured. This study will determine if perceived hearing benefit and speech recognition performance with the PD fitting method is non-inferior to that with the CD fitting method.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Native English speakers
  • Ability to complete questionnaires and laboratory assessments
  • Symmetric, mild to moderate sensorineural hearing loss
  • Informed consent completed with signature
  • Healthy outer ear/middle ear status
  • Limited hearing aid use (non-owners of hearing aids)

Exclusion criteria

  • Inability to visit the Starkey Headquarters building for testing
  • Central or middle ear hearing pathology
  • Medical contraindications to wearing hearing aids
  • Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
  • Hearing loss outside of the specified criteria (Mild to Moderate Sensorineural hearing loss)

Treatment and study plan

Self fitting hearing device

Device

comparison of outcomes when device is fit by clinician or self fit

Primary outcomes

  1. 1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB)

    Time frame: The timeframe for this data collection will be unaided, and 14 days post-fitting.

    This data will be collected through the APHAB (Abbreviated Profile of Hearing Aid Benefit). This is a 24-item survey of hearing aid benefit. This test will be administered in the unaided hearing aid condition, and in both the traditional and new fitting method conditions. Scores report the reduction in reported problems, and a higher score shows a larger reduction in problems in one condition than the other.

Secondary outcomes

  1. 1. Speech intelligibility - Quick Speech in Noise Test (QuickSIN)

    Time frame: Timeframe for this data collection will be unaided, and 14-days post-fitting.

    This data will be collected with the QuickSIN, which is an adaptive measure of speech recognition in background noise. Outcome score is reported in "dB SNR loss." A reduced SNR loss is a better score and implies that the lower score performs better than the higher score.

Sponsors and collaborators

Lead sponsor

Starkey Laboratories, Inc

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2022
Registry last updated
Nov 10, 2022

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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