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

S

Starkey

Status

Completed

Conditions

Hearing Loss
Hearing Loss, Sensorineural

Treatments

Device: Legacy Receiver-in-Canal Device
Device: New Receiver-in-Canal Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT05101083
PR 21001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

34 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

34 participants in 2 patient groups

Hearing Aid 1
Experimental group
Description:
New Receiver-in-Canal device, successor of previous device generation
Treatment:
Device: Legacy Receiver-in-Canal Device
Hearing Aid 2
Active Comparator group
Description:
Legacy Receiver-in-Canal device that is currently available on the market
Treatment:
Device: New Receiver-in-Canal Device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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