Effect of Hearing Aid Labeling on Speech Understanding Measures

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Audeo P hearing aid labeled as "Prescriptive"; Device: Audeo P hearing aid labeled as "OTC"

• Registration Number: NCT05274178
• Lead Sponsor: Sonova AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-10
• Study Start: 2022-05-26
• Primary Completion: 2022-06-16
• Study Completion: 2022-06-16
• Results First Submitted: 2023-05-31
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-20
• Last Update Submitted: 2023-06-20
• Results First Posted: 2023-07-10
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Naive listeners	Audeo P hearing aid labeled as "OTC"	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"
Naive listeners	Audeo P hearing aid labeled as "Prescriptive"	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"
Experienced users	Audeo P hearing aid labeled as "OTC"	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"
Experienced users	Audeo P hearing aid labeled as "Prescriptive"	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"

Primary Outcome Measures

Name	Time	Method
Quick Speech in Noise Test (QuickSIN)	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.

Trial Locations

Locations (1)

Sonova US; 🇺🇸 Aurora, Illinois, United States