Trial Outcomes & Findings for Personal Sound Amplification Smartphone Application Feasibility (NCT NCT03652909)

Last Updated: 2023-02-03

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

32 participants

Primary outcome timeframe

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

Results posted on

2023-02-03

Participant Flow

Recruitment occurred February through September 2021. Participants were recruited from the audiology and ear nose and throat clinics.

Not applicable. Enrollment and subject participation in the experiment occurred sequentially within the same study visit.

Participant milestones

Participant milestones
Measure	PSAD Patients try the personal sound amplification device. Ascending Hearing Technologies device: Personal Sound Amplification Device
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Personal Sound Amplification Smartphone Application Feasibility

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PSAD n=32 Participants Patients try the personal sound amplification device. Ascending Hearing Technologies device: Personal Sound Amplification Device
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants
Age, Categorical >=65 years	21 Participants n=93 Participants
Age, Continuous	62.1 years STANDARD_DEVIATION 12.8 • n=93 Participants
Sex: Female, Male Female	17 Participants n=93 Participants
Sex: Female, Male Male	15 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	29 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	32 participants n=93 Participants
Speech perception percent correct	57 percent words correct STANDARD_DEVIATION 34 • n=93 Participants
Sound quality: Words were clear	1.5 score on a scale STANDARD_DEVIATION 1.2 • n=93 Participants
Sound quality: Sentences were easy to understand	1.4 score on a scale STANDARD_DEVIATION 1.0 • n=93 Participants
Sound quality: sounds were distorted	2.5 score on a scale STANDARD_DEVIATION 1.3 • n=93 Participants

PRIMARY outcome

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

Population: All subjects

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.

Outcome measures

Outcome measures
Measure	Personal Amplification n=32 Participants Patients try the personal sound amplification device. Ascending Hearing Technologies device: Personal Sound Amplification Device
Sentence Perception in Noise Fine-tuned v Unamplified	78 percentage of words heard correctly Standard Deviation 20

PRIMARY outcome

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

Population: All subjects

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.

Outcome measures

Outcome measures
Measure	Personal Amplification n=32 Participants Patients try the personal sound amplification device. Ascending Hearing Technologies device: Personal Sound Amplification Device
Sentence Perception in Noise Initial Fit v Unamplified	83 percentage of words heard correctly Standard Deviation 18

SECONDARY outcome

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

Population: All subjects

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.

Outcome measures

Outcome measures
Measure	Personal Amplification n=32 Participants Patients try the personal sound amplification device. Ascending Hearing Technologies device: Personal Sound Amplification Device
Words Clear	2.6 score on a scale Standard Deviation 0.9

SECONDARY outcome

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

Population: All subjects

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.

Outcome measures

Outcome measures
Measure	Personal Amplification n=32 Participants Patients try the personal sound amplification device. Ascending Hearing Technologies device: Personal Sound Amplification Device
Sentences Easy to Understand	2.5 score on a scale Standard Deviation 1.1

SECONDARY outcome

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

Population: All subjects

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.

Outcome measures

Outcome measures
Measure	Personal Amplification n=32 Participants Patients try the personal sound amplification device. Ascending Hearing Technologies device: Personal Sound Amplification Device
Sounds Are Distorted	1.6 score on a scale Standard Deviation 1.0

Adverse Events

PSAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christina Runge

Ascending Hearing Technologies, LLC

Phone: 2623523478

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place