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

Starkey Laboratories, Inc34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hearing Loss, Sensorineural Hearing Loss

Interventions

New Receiver-in-Canal DeviceDEVICE

Successor of previous device generation

Legacy Receiver-in-Canal DeviceDEVICE

Receiver-in-canal device available on the market

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Starkey

Eden Prairie, Minnesota, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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