An interventional study of New Receiver-in-Canal Device and Legacy Receiver-in-Canal Device in Hearing Loss, Sensorineural and Hearing Loss, sponsored by Starkey Laboratories, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by Starkey Laboratories, Inc · Not applicable, Interventional, and Treatment
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.
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 34 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Starkey Laboratories, Inc is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
New Receiver-in-Canal device, successor of previous device generation
Device: Legacy Receiver-in-Canal Device
Legacy Receiver-in-Canal device that is currently available on the market
Device: New Receiver-in-Canal Device
Successor of previous device generation
Receiver-in-canal device available on the market
Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
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.
Time frame: Four weeks
First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids
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.
Time frame: Four weeks
Safety of the new, receiver-in-canal devices through tracking of adverse events
This data will be collected through the tracking of adverse events.
Time frame: Four weeks
Plan to share: No
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Starkey Laboratories, Inc