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OpenTrials
Completed

NCT Number: NCT03652909

Personal Sound Amplification Smartphone Application Feasibility

Find a personal sound amplification device that can help people hear better.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

Personal sound amplification devices (PSADs) have recently become available to the public. PSADs serve a potentially important role in providing audibility of sounds for adults who find themselves having difficulty hearing and understanding speech in some daily living situations, but may not be candidates for traditional, high-amplification hearing aids. Despite hearing loss being a very common problem, few adults who could benefit from some level of amplification actually access the technology. Only approximately 1 in 7 adults (14%) over the age of 50 with a hearing loss using amplification. High cost is the most commonly cited reason for not wanting to try amplification, and indeed, hearing aids range from $1000 to $5000 each (i.e., per ear). PSADs range from $50-$600 each, and may provide a reasonable option for people who are not ready, or are unwilling, to wear a hearing aid. This project aims to examine the feasibility of a PSAD to provide audible and clear sound signal to adult listeners. The significance of this project is its potential to develop an option for individuals to take advantage of amplification and access sound to improve quality of life, who may not otherwise do so without this technology.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults who report difficulty hearing in some daily listening situations.
  • Primarily English-speaking
  • Able to follow instructions and perform study procedures.

Exclusion criteria

  • Children
  • Non-English speaking
  • Unable to perform research procedures and/or follow necessary instructions

Treatment and study plan

Ascending Hearing Technologies device

Device

Personal Sound Amplification Device

Primary outcomes

  1. Sentence Perception in Noise Fine-tuned v Unamplified

    Time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes

    The fine-tuned Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly.

  2. Sentence Perception in Noise Initial Fit v Unamplified

    Time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes

    The prescription gain (initial fit) Personal Sound Amplification Device sound output will show speech perception benefit over the unamplified condition. Measure is percent of words heard correctly.

Secondary outcomes

  1. Words Clear

    Time frame: The patient will wear the personal sound amplification device on average for 30 minutes.

    The Likert Scale rating scale measures the subject's perception of how well he/she heard both with the Personal Sound Amplification Device and without the device.

    The patient will rate the following questions on a scale from Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'the words were clear.' Higher values mean better outcome.

  2. Sentences Easy to Understand

    Time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes

    The Likert Scale rating scale measures the subject's perception of how well he/she heard both with the Personal Sound Amplification Device and without the device.

    The patient will rate the following questions on a scale from Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'sentences were easy to understand.' Higher values mean better outcome.

  3. Sounds Are Distorted

    Time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes

    The patient will rate the following questions on a scale from Strongly Disagree (0), Disagree (1), Neutral (2), Agree (3), and Strongly Agree (4) for the statement 'the words were clear.' Lower values mean better outcome.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • University of Wisconsin, Milwaukee

Registry information

Official study title

Personal Sound Amplification Smartphone Application Feasibility Study

Acronym: PSAD

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2018
Registry last updated
Feb 3, 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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