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Clinical Trials/NCT05274178
NCT05274178
Completed
Not Applicable

Effect of Hearing Aid Labeling on Speech Understanding Measures

Sonova AG1 site in 1 country20 target enrollmentMay 26, 2022
ConditionsHearing Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Sonova AG
Enrollment
20
Locations
1
Primary Endpoint
Quick Speech in Noise Test (QuickSIN)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 26, 2022
End Date
June 16, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Sonova AG
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

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.

Study Sites (1)

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