Effect of Hearing Aid Labeling on Speech Understanding Measures

Hearing Loss Clinical Trial

Official title:

Effect of Hearing Aid Labeling on Speech Understanding Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05274178
• Other study ID #: SRF-505
• Status: Completed
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: June 16, 2022

Study information

• Verified date: June 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 16, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Sonova US	Aurora	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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