A Study to Compare Patient Perceptions of Two Different Hearing Aid Signal Processing Philosophies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sonova AG
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
Study Overview
Brief Summary
Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices. Participants will be asked to provide qualitative feedback to investigators regarding the performance of and their preference for each hearing instrument.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Identifying information will be removed from the hearing instruments before fitting the participants. However, participants may be able to research hearing instruments and identify devices based on physical appearance.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Moderate to severe sensorineural hearing loss
- •Current hearing aid user
Exclusion Criteria
- •Lack of willingness to wear study devices for approximately one month
- •Inability to travel to study appointments or to complete questionnaires.
Arms & Interventions
A-B-A
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Intervention: Receiver-in-canal hearing instrument; Manufacturer A (Device)
A-B-A
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument A Hearing instrument B Hearing instrument A
Intervention: Receiver-in-canal hearing instrument; Manufacturer B (Device)
B-A-B
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Intervention: Receiver-in-canal hearing instrument; Manufacturer A (Device)
B-A-B
Participants will be fit with hearing instruments A and B in the following order:
Hearing instrument B Hearing instrument A Hearing instrument B
Intervention: Receiver-in-canal hearing instrument; Manufacturer B (Device)
Outcomes
Primary Outcomes
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
Time Frame: End of home trial 1 (Day 10 of study)
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
Time Frame: End of home trial 3 (30 days after study start)
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn.
Time Frame: End of home trial 1 (Day 10 of study)
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. .
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn.
Time Frame: End of home trial 2 (Day 20 of study)
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B
Time Frame: End of home trial 2 (20 days after study start)
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn.
Time Frame: End of home trial 3 (Day 30 of study)
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
Secondary Outcomes
No secondary outcomes reported