A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification

Hearing Loss Clinical Trial

Official title:

A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03728907
• Other study ID #: 2183099
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2021
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. For the "audiologist fitting" technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification of output to match prescribed targets (NAL-NL2) and subsequent fine tuning to optimize adjustments based on participant feedback. The second technique is "user-adjustment" of the device consisting of adjustment to overall level, high-frequency boost, and low-frequency cut by the participant while listening to speech. A cross-over design will be used in which half the participants are initially fit using the audiologist technique and the other half are initially fit using the user self-adjustment technique. Following a seven-day field trial, participants will return to the lab and the aids will be reset use the other technique. Participants will be blinded to the condition. During each seven-day field trial, users will have access to a volume control, Following the end of the two trials, participants will return to the lab for outcome assessment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• bilateral hearing loss with a minimum of 40 dB HL thresholds at 2000 Hz

• English speaking

Exclusion Criteria:

• Score less than 21 on the MoCa (Montreal Cognitive Assessment)

• Evidence of conductive or retrocochlear pathology

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Hearing aid fitting technique- audiologist or user-adjusted
See information under 'arm' description

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	University of California, San Diego

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-ear aided output	aided output (in dB SPL) measured across frequencies in the ears of the participants	two weeks
Secondary	Device Oriented Scale of Improvement (DOSO)	Questionnaire (25 items) to assess benefit from hearing aids on a 7 pt scale; a larger number is associated with better outcome	two weeks
Secondary	Computerized Assisted Speech Perception Assessment (CASPA)	Speech recognition test; phoneme recognition score as percentage correct	two weeks