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Completed

NCT Number: NCT04839289

Hearing Aid Signal Processing Comparative Study

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phonak Audiology Research Center

Aurora, Illinois, 60504, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Receiver-in-canal hearing instrument; Manufacturer A

Device

Commercially available receiver-in-canal hearing instrument from manufacturer A

Receiver-in-canal hearing instrument; Manufacturer B

Device

Commercially available receiver-in-canal hearing instrument from manufacturer B

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

    .

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2021
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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