Clinical trial NCT05612763: Self Fitting Hearing Aid Clinical Investigation
Official title: Self Fitting Hearing Aid Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Keywords: self fitting
Lead sponsor: Starkey Laboratories, Inc
Sponsor class: INDUSTRY
First posted: 2022-11-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The participants will have three lab sessions and two field trials. In the first session, every participant will receive PD and CD fittings. The wearing schedule orders for all the participants will be counterbalanced. For the first field trial, half of the participants will wear the hearing aids with PD and the other half of the participants will wear the hearing aids with CD. In session two, outcomes for the first hearing aid condition will be measured. Then, the participants will wear hearing aids with the other type of fitting strategy for the second field trial. After that, they will return to the lab for session 3, in which outcomes for the second hearing aid condition will be measured. Outcome measures include a self-report field evaluation (Abbreviated Profile of Hearing Aid Benefit, or APHAB) and a lab-based speech recognition test (Quick Speech-in-Noise Test, Quick-SIN).
Primary purpose: TREATMENT

Brief summary: Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids

Detailed description: The purpose of this study is to evaluate the outcomes of hearing aids with patient-driven fitting (PD) and clinician-driven fitting (CD). The participants will be 40 adults with mild to moderate symmetrical hearing loss. For each hearing aid fitting strategy, the participant will wear the hearing aids for 10 days. Lab and field outcomes will be measured. This study will determine if perceived hearing benefit and speech recognition performance with the PD fitting method is non-inferior to that with the CD fitting method.

Eligibility criteria: Inclusion Criteria:

1. Native English speakers
2. Ability to complete questionnaires and laboratory assessments
3. Symmetric, mild to moderate sensorineural hearing loss
4. Informed consent completed with signature
5. Healthy outer ear/middle ear status
6. Limited hearing aid use (non-owners of hearing aids)

Exclusion criteria:

1. Inability to visit the Starkey Headquarters building for testing
2. Central or middle ear hearing pathology
3. Medical contraindications to wearing hearing aids
4. Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
5. Hearing loss outside of the specified criteria (Mild to Moderate Sensorineural hearing loss)

Primary outcomes:
measure: 1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: The timeframe for this data collection will be unaided, and 14 days post-fitting.
Secondary outcomes:
measure: 1. Speech intelligibility - Quick Speech in Noise Test (QuickSIN)
timeFrame: Timeframe for this data collection will be unaided, and 14-days post-fitting.
Other outcomes:
Locations:
city: Eden Prairie
country: United States
facility: Starkey Laboratories
state: Minnesota
Study officials:
affiliation: VP education and Clinical Studies
name: Michelle Hicks, PhD
role: STUDY_DIRECTOR
References: