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Hearing Aid Signal Processing Comparative Study

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ClinicalTrials.gov Identifier: NCT04839289
Recruitment Status : Not yet recruiting
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Device: Receiver-in-canal hearing instrument; Manufacturer A Device: Receiver-in-canal hearing instrument; Manufacturer B Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Primary Purpose: Treatment
Official Title: A Study to Compare Patient Perceptions of Two Different Hearing Aid Signal Processing Philosophies
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
Experimental: 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

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

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

Experimental: 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

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

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




Primary Outcome Measures :
  1. Custom designed questionnaire [ Time Frame: End of home trial 1 (10 days after study start) ]
    Qualitative feedback questionnaire authored by the investigators to gather feedback on particular areas of focus.

  2. Custom designed questionnaire [ Time Frame: End of home trial 2 (20 days after study start) ]
    Qualitative feedback questionnaire authored by the investigators to gather feedback on particular areas of focus.

  3. Custom designed questionnaire [ Time Frame: End of home trial 3 (30 days after study start) ]
    Qualitative feedback questionnaire authored by the investigators to gather feedback on particular areas of focus.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839289


Contacts
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Contact: Kevin Seitz-Paquette, AuD 3313301608 kevin.seitz-paquette@sonova.com

Locations
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United States, Illinois
Phonak Audiology Research Center
Aurora, Illinois, United States, 60504
Contact: Kevin Seitz-Paquette, AuD    331-330-1608    kevin.seitz-paquette@sonova.com   
Sponsors and Collaborators
Sonova AG
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Responsible Party: Sonova AG
ClinicalTrials.gov Identifier: NCT04839289    
Other Study ID Numbers: SRF-311
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases