Clinical trial NCT05376215: A Comparison of Hearing Aid Fitting Methods
Official title: A Comparison of Hearing Aid Fitting Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: University of South Florida
First posted: 2022-05-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a prospective, repeated measures, within-subject, cross over design. Subjects will be assigned in random order to the two fitting methods. Subjects will be blinded as to which fitting method they are using during the home trials.
Primary purpose: TREATMENT

Brief summary: This investigation will compare hearing aid fitting methods between self-fitting and clinician fitting approaches by using a standardized questionnaire to evaluate subjective hearing aid benefit.

Detailed description: Participants will be fit with hearing aids using two different fitting methods (fitting A and fitting B). The order of the fitting will be randomized such that half of the participants will start out with fitting A and half of the participants will start out with fitting B. All participants will undergo baseline speech testing and answer a questionnaire about their experiences in daily life without hearing aids. All participants will use devices for a period of 1-2 weeks in their daily lives. After this first home trial, participants will return to the clinic where they will answer questionnaires regarding their experience with the devices. They will also perform aided speech testing. They will then be given devices with the second fitting method and will wear devices for a period of 1-2 weeks in their daily lives. Following the second home trial, all participants will return to the clinic to answer the same questionnaire that was given after home trial #1, and complete aided speech testing. The results for each of the two fitting methods will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate bilateral hearing loss
* First time (new) hearing aid users or experienced hearing aid users
* Ability to use a smartphone
* Fluent in English; ability to read and write in English
* Willing and able to provide informed consent

Exclusion Criteria:

* Self reported ear-related pathology including otorrhea within 90 days, dizziness, sudden onset or worsening of hearing loss within 90 days, visible deformity of the ear, otalgia
* Unilateral hearing loss
* Chronic, severe tinnitus

Primary outcomes:
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Day 1 (unaided testing), Day 14(aided testing for first fitting method) and Day 28 (aided testing for second fitting method) of study
Secondary outcomes:
measure: Speech Perception in Noise, Expressed in Decibel (dB) Signal to Noise Ratio (SNR) Loss
timeFrame: Day 1 (unaided/baseline testing) of study, day 14 (aided testing with first fitting method) and day 28 (aided testing with second fitting method) of study
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References: