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

NCT05101083 | Completed FDA Device

• 1 other identifier: PR 21001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Four weeks

Secondary Outcomes (2)

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

  Four weeks

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

  Four weeks

Study Arms (2)

Hearing Aid 1

EXPERIMENTAL

New Receiver-in-Canal device, successor of previous device generation

Device: Legacy Receiver-in-Canal Device

Hearing Aid 2

ACTIVE COMPARATOR

Legacy Receiver-in-Canal device that is currently available on the market

Device: New Receiver-in-Canal Device

Interventions

New Receiver-in-Canal Device DEVICE

Successor of previous device generation

Hearing Aid 2

Legacy Receiver-in-Canal Device DEVICE

Receiver-in-canal device available on the market

Hearing Aid 1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Starkey Laboratories, Inc: lead

Study Sites (1)

Starkey

Eden Prairie, Minnesota, 55344, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover Assignment - Each participant will experience both test conditions (counterbalanced)

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 1, 2021
• Study Start: October 25, 2021
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)