Effect of Hearing Aid Labeling on Speech Understanding Measures

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-26

Study Completion Date

2022-06-16

Brief Summary

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

New and experienced hearing aid users will be fit with two hearing devices. One will be labeled as an OTC (Over-The-Counter) device, the other will be labeled as a Prescriptive (i.e. professionally fit) device. Both devices will be generically programmed for a mild to moderate hearing loss. An objective speech in noise test will be completed with both devices.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Hearing Aid Benefit

NCT05198713

Hearing Loss, Sensorineural

COMPLETED NA

A Comparison of Hearing Aid Noise Programs on Speech Intelligibility

NCT06957730

Hearing Loss, Bilateral or Unilateral

COMPLETED NA

Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_12

NCT03554577

Hearing Loss

COMPLETED NA

Evaluating Benefits of Hearing Aid Microphone Directionality Technologies

NCT04953390

Hearing Loss

COMPLETED NA

In Field Performance of a Hearing Aid Transducer

NCT04787055

Hearing Loss

COMPLETED NA

Detailed Description

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

Conditions

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

Hearing Loss

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

A single group of participants will be involved in this study. All participants will be evaluated with both hearing devices.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Participants will be told they are wearing either a prescriptive hearing aid or an OTC (Over-The-Counter) hearing device based on the labeling of the hearing aids. Both sets of devices will actually be the same. The investigator that is scoring the objective speech in noise test will not know which device the participant is wearing at the time of the test (i.e., the set that is labeled as prescriptive or the set that is labeled as OTC).

Study Groups

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

Naive listeners

Participants who have never worn a hearing aid before. This group will be tested with both sets of devices, those labeled as "OTC" and those labeled as "Prescriptive"

Group Type EXPERIMENTAL

Audeo P hearing aid labeled as "Prescriptive"

Intervention Type DEVICE

The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.

Audeo P hearing aid labeled as "OTC"

Intervention Type DEVICE

The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.

Experienced users

Participants who have at least six months experience wearing hearing aids. This group will be tested with both sets of devices, those labeled as "OTC", and those labeled as "Prescriptive"

Group Type EXPERIMENTAL

Audeo P hearing aid labeled as "Prescriptive"

Intervention Type DEVICE

The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.

Audeo P hearing aid labeled as "OTC"

Intervention Type DEVICE

The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.

Interventions

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

Audeo P hearing aid labeled as "Prescriptive"

The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.

Intervention Type DEVICE

Audeo P hearing aid labeled as "OTC"

The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.

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 age 18 or older with bilateral mild to moderate hearing loss
* Experienced users must have at least 6 months Hearing Aid experience
* New users must have no prior hearing aid experience, defined as never owning their own devices

Exclusion Criteria

* Self-reported ear related pathology (otorrhea w/in 90 days, dizziness, sudden hearing loss or worsening of hearing w/in 90 days, otalgia)
* Visible deformity of the ear
* Chronic, severe tinnitus
* Unilateral hearing loss
* Cognitive impairment

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes