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

NCT ID: NCT05101083

Last Updated: 2022-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2022-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss, Sensorineural Hearing Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment - Each participant will experience both test conditions (counterbalanced)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hearing Aid 1

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

Group Type EXPERIMENTAL

Legacy Receiver-in-Canal Device

Intervention Type DEVICE

Receiver-in-canal device available on the market

Hearing Aid 2

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

Group Type ACTIVE_COMPARATOR

New Receiver-in-Canal Device

Intervention Type DEVICE

Successor of previous device generation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

New Receiver-in-Canal Device

Successor of previous device generation

Intervention Type DEVICE

Legacy Receiver-in-Canal Device

Receiver-in-canal device available on the market

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Starkey Laboratories, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Starkey

Eden Prairie, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PR 21001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Remote Microphone Candidacy Study
NCT03897634 COMPLETED NA
Opto-electrical Cochlear Implants
NCT05110183 ENROLLING_BY_INVITATION NA