N/A N=20 Single-blind Treatment

Effect of Hearing Aid Labeling on Speech Understanding Measures

Hearing Loss

Bottom Line

View on ClinicalTrials.gov: NCT05274178 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Quick Speech in Noise Test (QuickSIN) — 6.2; 9.6; 5.2; 10 decibels (dB) — p=>.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Audeo P hearing aid labeled as "Prescriptive" (Device); Audeo P hearing aid labeled as "OTC" (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sonova AG
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Quick Speech in Noise Test (QuickSIN)	6.2; 9.6; 5.2; 10	>.05

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05274178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.