Effect of Hearing Aid Labeling on Speech Understanding Measures

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.

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Key information

Conditions

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

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova US

Aurora, Illinois, 60505, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audeo P hearing aid labeled as "Prescriptive"

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"

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.

Primary outcomes

Quick Speech in Noise Test (QuickSIN)

Time frame: Day 1 of 1 day study

A speech in noise test in which participant repeats sentences in variable levels of background noise. Test result is reported as the signal to noise level at which participant can repeat 50% of the words correctly. A lower score/dB SNR (decibel Signal to Noise Ratio) level indicates better speech in noise perception. For example, a score of 0 dB would indicate that the participant can repeat 50% of the words presented when the speech signal and the noise are presented at the same level. A score of 6 dB would indicate that the participant needs the speech signal 6 dB louder than the noise in order to correctly repeat 50% of the words presented. Scores can range from negative db SNR (e.g. -5 dB, which would be a good score and indicate little difficulty in noise) to quite high (e.g. +15 dB, which would be a poorer score and indicate much difficulty in noise) In this case, the scores ranged from +2 to +18 dB.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Mar 10, 2022
Registry last updated: Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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