Clinical trial NCT03345654: Individually-guided Hearing Aid Fitting
Official title: Characterizing Variability in Hearing Aid Outcomes Among Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Boulder
First posted: 2017-11-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population will be recruited from the Northwestern University Center for Audiology, Speech, Learning, and Language. They will be adults (18+) who are new hearing aid users with no recent prior hearing aid experience. Any patient at the clinic who purchases a new pair of hearing aids and meets the study criteria will be provided information about the study.

Brief summary: This translational project aims to optimize the fitting of hearing aids by development and clinical validation of a toolset that guides signal processing choice based on the individual auditory and cognitive abilities of the patient.

Detailed description: The clinical trial portion of the project will validate clinical use of the toolset by evaluating a population of patients fit using current standard of care. Patient characteristics, such as audiological profile and cognition, will be collected. Their hearing aid settings will then be evaluated to determine if they meet toolset guidelines for signal processing based on their patient characteristics (auditory and cognition). Data regarding subjective and objective hearing aid outcomes will also be collected. It is hypothesized that hearing aid fittings that meet the standards of the proposed clinical toolset will result in better patient outcomes (objective and subjective) and fewer post-fitting visits.

Eligibility criteria: Inclusion Criteria:

* sensorineural hearing loss with pure-tone thresholds 70 dB HL or better at octave frequencies between 250 and 4000 Hz, 4 (.5, 1, 2, 3 kHz)
* frequency pure-tone average (PTA) of ≥ 30 dB HL.
* Listeners will have symmetrical losses, defined here as a 4-frequency PTA difference between ears ≤ 20 dB HL.

Exclusion Criteria:

* recent (within last 12 months) hearing aid use
* conductive loss (air-bone gaps \> 10 dB at any frequency and/or abnormal immittance) -
* scoring \< 23 on the Montreal Cognitive Assessment
* Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
* Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
* Significant history of otologic or neurologic disorders
* Non English speaking participants
* Any clinically significant unstable or progressive medical condition
* Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.

Primary outcomes:
measure: Speech intelligibility
timeFrame: Baseline at initial fit, then post-intervention at final hearing aid appointment, about 30 days later
Secondary outcomes:
measure: Post-fitting adjustment visits
timeFrame: First 30 days of fitting
measure: Speech and Spatial qualities questionnaire (SSQ)
timeFrame: Baseline at initial fit, then post intervention at final hearing aid appointment, about 30 days later
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: