Hearing Aid Signal Processing Comparative Study
A Study to Compare Patient Perceptions of Two Different Hearing Aid Signal Processing Philosophies
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
April 9, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedResults Posted
Study results publicly available
March 22, 2023
CompletedMarch 22, 2023
July 1, 2021
2 months
February 25, 2021
January 4, 2023
February 24, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
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
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).
End of home trial 1 (Day 10 of study)
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
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).
End of home trial 2 (20 days after study start)
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
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).
End of home trial 3 (30 days after study start)
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn.
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. .
End of home trial 1 (Day 10 of study)
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn.
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.
End of home trial 2 (Day 20 of study)
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn.
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.
End of home trial 3 (Day 30 of study)
Study Arms (2)
A-B-A
EXPERIMENTALParticipants will be fit with hearing instruments A and B in the following order: Hearing instrument A Hearing instrument B Hearing instrument A
B-A-B
EXPERIMENTALParticipants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B
Interventions
Commercially available receiver-in-canal hearing instrument from manufacturer A
Commercially available receiver-in-canal hearing instrument from manufacturer B
Eligibility Criteria
You may qualify if:
- Moderate to severe sensorineural hearing loss
- Current hearing aid user
You may not qualify if:
- Lack of willingness to wear study devices for approximately one month
- Inability to travel to study appointments or to complete questionnaires.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Phonak Audiology Research Center
Aurora, Illinois, 60504, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Standaert
- Organization
- Sonova USCS
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2021
First Posted
April 9, 2021
Study Start
July 1, 2021
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
March 22, 2023
Results First Posted
March 22, 2023
Record last verified: 2021-07