Self Fitting Hearing Aid Clinical Investigation

Hearing Loss, Sensorineural Clinical Trial

Official title:

Self Fitting Hearing Aid Clinical Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05612763
• Other study ID #: GQ-PRO-06093
• Status: Completed
• Phase: N/A
• Start date: August 18, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: November 2022
• Source: Starkey Laboratories, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 10, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Seizures

Intervention

Device:
• Self fitting hearing device
comparison of outcomes when device is fit by clinician or self fit

Locations

Country	Name	City	State
United States	Starkey Laboratories	Eden Prairie	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Starkey Laboratories, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB)	This data will be collected through the APHAB (Abbreviated Profile of Hearing Aid Benefit). This is a 24-item survey of hearing aid benefit. This test will be administered in the unaided hearing aid condition, and in both the traditional and new fitting method conditions. Scores report the reduction in reported problems, and a higher score shows a larger reduction in problems in one condition than the other.	The timeframe for this data collection will be unaided, and 14 days post-fitting.
Secondary	1. Speech intelligibility - Quick Speech in Noise Test (QuickSIN)	This data will be collected with the QuickSIN, which is an adaptive measure of speech recognition in background noise. Outcome score is reported in "dB SNR loss." A reduced SNR loss is a better score and implies that the lower score performs better than the higher score.	Timeframe for this data collection will be unaided, and 14-days post-fitting.