Hearing LossPSADNCT03652909
Personal Sound Amplification Smartphone Application Feasibility
An observational study of Hearing Loss, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Find a personal sound amplification device that can help people hear better. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Ascending Hearing Technologies device
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 20 Sep 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults who report difficulty hearing in some daily listening situations
Who may be able to join
- Adults who report difficulty hearing in some daily listening situations.
- Primarily English-speaking
- Able to follow instructions and perform study procedures.
Who cannot join
- Children
- Non-English speaking
- Unable to perform research procedures and/or follow necessary instructions
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Personal Sound Amplification Smartphone Application Feasibility Study
Find a personal sound amplification device that can help people hear better.
Read the detailed description
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.
- Conditions
- Hearing Loss
- Being tested
- Ascending Hearing Technologies device
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascending Hearing Technologies deviceDevice
Personal Sound Amplification Device
| Study group | Role | What they receive |
|---|---|---|
| Adults with difficulty hearing in some daily listening situations | Patients listen to sounds with and without the personal sound amplification smartphone application Receives: Device: Ascending Hearing Technologies device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentence Perception in Noise Fine-tuned v Unamplified
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.
Measured: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Sentence Perception in Noise Initial Fit v Unamplified
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.
Measured: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Secondary outcomes (3)
Words Clear
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.
Measured: The patient will wear the personal sound amplification device on average for 30 minutes.
Sentences Easy to Understand
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.
Measured: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Sounds Are Distorted
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.
Measured: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start26 Feb 2021
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Christina L Runge, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652909
- Sponsor's protocol ID
- PRO00032080
- Other IDs
- R41DC017939
- Acronym
- PSAD
- Status last verified
- Jan 2023
- First submitted
- 27 Aug 2018
- Last updated
- 3 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Sound Amplification Smartphone Application Feasibility Study
- ClinicalTrials.gov ID
- NCT03652909
- Acronym / sponsor ID
- PSAD / PRO00032080
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Posted 3 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Find a personal sound amplification device that can help people hear better.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with difficulty hearing in some daily listening situations | – | Device: Ascending Hearing Technologies devicePatients listen to sounds with and without the personal sound amplification smartphone application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who report difficulty hearing in some daily listening situations
Key inclusion criteria (3 listed)
- Adults who report difficulty hearing in some daily listening situations.
- Primarily English-speaking
- Able to follow instructions and perform study procedures.
Key exclusion criteria (3 listed)
- Children
- Non-English speaking
- Unable to perform research procedures and/or follow necessary instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascending Hearing Technologies devicePersonal Sound Amplification Device | Device | Adults with difficulty hearing in some daily listening situations |
Primary outcome
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.
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.
3 secondary outcomes
Words Clear
Time frame: The patient will wear the personal sound amplification device on average for 30 minutes.
Sentences Easy to Understand
Time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Sounds Are Distorted
Time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Hearing Loss
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina L Runge, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentence Perception in Noise Fine-tuned v Unamplified (time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023; AzTrials last refreshed its copy on 29 Oct 2026.