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Hearing Aid Signal Processing Comparative Study

Not Applicable
Completed
Conditions
Hearing Loss, Sensorineural
Interventions
Device: Receiver-in-canal hearing instrument; Manufacturer A
Device: Receiver-in-canal hearing instrument; Manufacturer B
Registration Number
NCT04839289
Lead Sponsor
Sonova AG
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
27
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
A-B-AReceiver-in-canal hearing instrument; Manufacturer AParticipants will be fit with hearing instruments A and B in the following order: Hearing instrument A Hearing instrument B Hearing instrument A
A-B-AReceiver-in-canal hearing instrument; Manufacturer BParticipants will be fit with hearing instruments A and B in the following order: Hearing instrument A Hearing instrument B Hearing instrument A
B-A-BReceiver-in-canal hearing instrument; Manufacturer BParticipants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B
B-A-BReceiver-in-canal hearing instrument; Manufacturer AParticipants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B
Primary Outcome Measures
NameTimeMethod
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-BEnd 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-BEnd 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.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.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-BEnd 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.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 Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Phonak Audiology Research Center

🇺🇸

Aurora, Illinois, United States

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