Effect of Hearing Aid Labeling on Speech Understanding Measures

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Audeo P hearing aid labeled as "Prescriptive"; Device: Audeo P hearing aid labeled as "OTC"

Study type: Interventional

Funder types: Industry

Identifiers

NCT05274178

SRF-505

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Naive listeners

Experimental group

Description:

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"

Treatment:

Device: Audeo P hearing aid labeled as "Prescriptive"

Device: Audeo P hearing aid labeled as "OTC"

Experienced users

Experimental group

Description:

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"

Treatment:

Device: Audeo P hearing aid labeled as "Prescriptive"

Device: Audeo P hearing aid labeled as "OTC"