Hearing Loss
Conditions
Brief summary
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.
Interventions
DEVICEAscending Hearing Technologies device
Personal Sound Amplification Device
Sponsors
University of Wisconsin, Milwaukee
National Institute on Deafness and Other Communication Disorders (NIDCD)
Medical College of Wisconsin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sentence Perception in Noise Fine-tuned v Unamplified | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Words Clear | 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. |
| Sentences Easy to Understand | 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. |
| Sounds Are Distorted | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred February through September 2021. Participants were recruited from the audiology and ear nose and throat clinics.
Pre-assignment details
Not applicable. Enrollment and subject participation in the experiment occurred sequentially within the same study visit.
Participants by arm
| Arm | Count |
|---|---|
| PSAD Patients try the personal sound amplification device.
Ascending Hearing Technologies device: Personal Sound Amplification Device | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | PSAD |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 62.1 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 15 Participants |
| Sound quality: Sentences were easy to understand | 1.4 score on a scale STANDARD_DEVIATION 1 |
| Sound quality: sounds were distorted | 2.5 score on a scale STANDARD_DEVIATION 1.3 |
| Sound quality: Words were clear | 1.5 score on a scale STANDARD_DEVIATION 1.2 |
| Speech perception percent correct | 57 percent words correct STANDARD_DEVIATION 34 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
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.
Time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Population: All subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personal Amplification | Sentence Perception in Noise Fine-tuned v Unamplified | 78 percentage of words heard correctly | Standard Deviation 20 |
Primary
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.
Time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Population: All subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personal Amplification | Sentence Perception in Noise Initial Fit v Unamplified | 83 percentage of words heard correctly | Standard Deviation 18 |
Secondary
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.
Time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Population: All subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personal Amplification | Sentences Easy to Understand | 2.5 score on a scale | Standard Deviation 1.1 |
Secondary
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.
Time frame: The patient will wear the Personal Sound Amplification Device for approximately 30 minutes
Population: All subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personal Amplification | Sounds Are Distorted | 1.6 score on a scale | Standard Deviation 1 |
Secondary
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.
Time frame: The patient will wear the personal sound amplification device on average for 30 minutes.
Population: All subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personal Amplification | Words Clear | 2.6 score on a scale | Standard Deviation 0.9 |