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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03728907
Enrollment
0
Registered
2018-11-02
Start date
2021-08-01
Completion date
2022-05-31
Last updated
2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

hearing aid, self-fitting

Brief 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.

Interventions

DEVICEHearing aid fitting technique- audiologist or user-adjusted

See information under 'arm' description

Sponsors

University of California, San Diego
CollaboratorOTHER
San Diego State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Outcomes assessors and participants will not be aware of which hearing setting (audiologist adjusted vs. self-adjusted) they are wearing

Intervention model description

Repeated-measures crossover design

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Real-ear aided outputtwo weeksaided output (in dB SPL) measured across frequencies in the ears of the participants

Secondary

MeasureTime frameDescription
Computerized Assisted Speech Perception Assessment (CASPA)two weeksSpeech recognition test; phoneme recognition score as percentage correct
Device Oriented Scale of Improvement (DOSO)two weeksQuestionnaire (25 items) to assess benefit from hearing aids on a 7 pt scale; a larger number is associated with better outcome

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026