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OpenTrials
Completed

NCT Number: NCT05101083

Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids

This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.

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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–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Starkey

Eden Prairie, Minnesota, 55344, United States

About this study

Starkey is investigating a new hearing aid with several new audiological features. These features have been assessed for benefit, individually, but this clinical investigation will serve as a test for safety and efficacy with all hearing aid features, together. The design of this study is a single-blinded, crossover design and will be conducted at Starkey's headquarters in Eden Prairie, MN.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults, minimum age of 18
  • Native English speakers
  • Ability to complete questionnaires and laboratory assessments
  • Symmetric, mild to moderately-severe sensorineural hearing loss
  • Informed consent completed with signature

Exclusion criteria

  • Inability to visit the Starkey Headquarters building for testing
  • Central or middle ear hearing problems
  • 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

Treatment and study plan

New Receiver-in-Canal Device

Device

Successor of previous device generation

Legacy Receiver-in-Canal Device

Device

Receiver-in-canal device available on the market

Primary outcomes

  1. Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids

    Time frame: Four weeks

    IEEE sentences will be presented to the research participants in quiet and in background noise. The percent words repeated back correctly will be scored and serve as the reported result of this outcome measure.

Secondary outcomes

  1. First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids

    Time frame: Four weeks

    This data will be collected through lab testing following the first fit of the hearing aids. Participants will answer questionnaire items related to their impressions of sound quality. Results will be collected using a 7-point Likert scale, and ratings (1-7) will be analyzed using descriptive statistics. Statistical measures for repeated measurements will be used to understand any differences between hearing aid conditions.

  2. Safety of the new, receiver-in-canal devices through tracking of adverse events

    Time frame: Four weeks

    This data will be collected through the tracking of adverse events.

Sponsors and collaborators

Lead sponsor

Starkey Laboratories, Inc

Industry

Registry information

Official study title

Speech Intelligibility in Quiet and Noise for New Versus Legacy Hearing Aids

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2021
Registry last updated
Jan 18, 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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