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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Audeo P hearing aid labeled as "Prescriptive"; Device: Audeo P hearing aid labeled as "OTC"

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Aurora, Illinois, United States, 60505
      • Sonova US

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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"	Device: 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.; 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.
Experimental: 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"	Device: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Speech in Noise Test (QuickSIN)	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.	Day 1 of 1 day study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of Amplification in Daily Life (SADL)	Validated subjective questionnaire for experienced hearing aid users rating their satisfaction with their hearing devices in daily activities, on a scale from 1(Not at all) to 7 (Tremendously). A higher score indicates more satisfaction with hearing aids in daily life.	Day 1 of 1 day study
Expected Consequences of Hearing Aid Ownership (ECHO)	Validated subjective questionnaire for inexperienced hearing aid users rating their expectations of hearing aid satisfaction and performance, on a scale from 1(Not at all) to 7(Tremendously). A higher score indicates higher expectations, including higher expected satisfaction from hearing aids.	Day 1 of 1 day study
Big Five Personality Inventory	A validated, 44 item inventory that measures an individual on the Big Five Factors of personality. Participants rate themselves on different characteristics using a scale from 1 (I disagree strongly) to 5(agree strongly).Subscales on extraversion, agreeableness, conscientiousness, neuroticism, and openness are scored and a higher number indicates a tendency toward that particular trait.	Day 1 of 1 day study

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): June 16, 2022

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: SRF-505

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes