Hearing Aid Signal Processing Comparative Study

Hearing Loss, Sensorineural Clinical Trial

Official title:

A Study to Compare Patient Perceptions of Two Different Hearing Aid Signal Processing Philosophies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839289
• Other study ID #: SRF-311
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: July 2021
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• Receiver-in-canal hearing instrument; Manufacturer A
Commercially available receiver-in-canal hearing instrument from manufacturer A
• Receiver-in-canal hearing instrument; Manufacturer B
Commercially available receiver-in-canal hearing instrument from manufacturer B

Locations

Country	Name	City	State
United States	Phonak Audiology Research Center	Aurora	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)