Trial Outcomes & Findings for Audiobooks for Hearing Loss App as Auditory Training (NCT NCT04231396)

Last Updated: 2022-01-14

Results Overview

Speech in noise test; partial BKB-SIN hearing test. SNR Loss scores based on normative sample data on decibel (dB) measures. where Minimum value is 0 dB, Maximum value 15+ dB. Lower scores mean better outcome, 0-3dB = hearing normal; 3-7 dB = Mild SNR loss; 7-15 dB = Moderate SNR loss; \>15 db = Severe SNR loss. Slopes of BKB-SIN (Background Noise partial tests) were measured from the Auditory Training portion of the study: weeks 7-12. We used a smoothing method for statistical analysis: isotonic regression (isoreg(), via R). This method is the fundamental assumption that the scores of these 6 weeks will be non-increasing indicating better outcome; improved listening scores on the BKB-SIN partial tests.

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

6 weeks

Results posted on

2022-01-14

Participant Flow

The COVID-19 pandemic impacted recruitment efforts. Participants were recruited by flyers and posted at multiple sources, including local healthcare specialists (Audiologist and Otolaryngologist offices), schools, and hearing loss support group meetings. Participants were recruited via Facebook ad on Hospitals' Facebook Pages. Recruitment occurred between February 2021 and June 2021. The first participant enrolled on February 25, 2021 and the last participant enrolled on June 23, 2021.

Participant milestones

Participant milestones
Measure	HA and CI Users Using Audiobooks for Hearing Loss App as Auditory Training \The COVID-19 Pandemic and low enrollment numbers for certain HL subgroups in the study caused an imbalance of subgroup numbers for comparisons, therefore, the effectiveness of the Audiobooks for Hearing Loss App was measured for the overall group. Study participants were seen for 12 weeks and used the Audiobooks for HL App for the final 6 weeks using the App at least two hours per week on their own. The researcher conducted 12 weekly visits where the following was done: First 6 weeks: • Administer partial BKB-SIN test Final 6 weeks: Administer partial BKB-SIN test * Conduct a comprehension test. * Address any usability issues the participant brings up. * Review and set new weekly goals Final session: Conduct Final Usability survey
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Audiobooks for Hearing Loss App as Auditory Training

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HA and CI Users Using the Audiobooks for Hearing Loss App as Auditory Training n=27 Participants \The COVID-19 Pandemic and low enrollment numbers for certain HL subgroups in the study caused an imbalance of subgroup numbers for comparisons, therefore, the effectiveness of the Audiobooks for Hearing Loss App was measured for the overall group. Study participants were seen for 12 weeks and used the Audiobooks for HL App for the final 6 weeks using the App at least two hours per week on their own. The researcher conducted 12 weekly visits where the following was done: First 6 weeks: • Administer partial BKB-SIN test Final 6 weeks: Administer partial BKB-SIN test * Conduct a comprehension test. * Address any usability issues the participant brings up. * Review and set new weekly goals Final session: Conduct Final Usability survey
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants
Hearing Loss resulting in: HA or CI	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	HA and CI Users Using the Audiobooks for Hearing Loss App as Auditory Training n=27 Participants Study participants will use the Audiobooks for HL App for 12 weeks using the App at least two hours per week on their own. The researcher will conduct 12 weekly visits where the following will be done: First 6 weeks: • Partial BKB-SIN will be administered Final 6 weeks: * Partial BKB-SIN will be administered * Conduct a comprehension test. * Address any usability issues the participant brings up. * Review and set new weekly goals Final session: Conduct Final Usability survey of the App
Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test week 7	5.978 units on a scale/week Standard Deviation .712
Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test week 8	5.889 units on a scale/week Standard Deviation .716
Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test week 9	5.757 units on a scale/week Standard Deviation .720
Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test week 10	5.600 units on a scale/week Standard Deviation .711
Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test week 11	5.398 units on a scale/week Standard Deviation .708
Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test week 12	5.088 units on a scale/week Standard Deviation .725

SECONDARY outcome

Timeframe: 6 weeks

Percentage of positive answers on Final Usability Survey: "Would you buy or recommend the Audiobooks for Hearing Loss App for yourself or someone you know who recently got a new Hearing Aid or Cochlear Implant." Clients filled out final usability survey at end of 12-week study.

Outcome measures

Outcome measures
Measure	HA and CI Users Using the Audiobooks for Hearing Loss App as Auditory Training n=27 Participants Study participants will use the Audiobooks for HL App for 12 weeks using the App at least two hours per week on their own. The researcher will conduct 12 weekly visits where the following will be done: First 6 weeks: • Partial BKB-SIN will be administered Final 6 weeks: * Partial BKB-SIN will be administered * Conduct a comprehension test. * Address any usability issues the participant brings up. * Review and set new weekly goals Final session: Conduct Final Usability survey of the App
Audiobooks Positive Responses: Percentage of Positive Responses to Final Usability Survey Question: Would You Buy or Recommend Audiobooks for HL App as Auditory Training	77 percentage of positive answers

SECONDARY outcome

Timeframe: 6 weeks

Meeting specific weekly goals (yes/no) for using the Audiobooks for HL App with was a measure of adherence to this Auditory Training program. Researcher tracked whether HA and CI Users met their weekly goals during weekly check-ins. The researcher recorded information from the App's dashboard about whether the client had met the previous week's goals. The dashboard shows the Client's weekly goals of: Minutes of listening, minutes of listening in Standard Speech, minutes of Pure Listening (audio only), minutes of no text support, minutes of listening in background noise. New goals were updated for the upcoming week with increased difficulty based on goal performance. The scale used for the overall mean scores reported is 0 to 1.0 where the minimum value is 0 and maximum value is 1. Computing in percentage 0 = 0% for meeting that specific goal and 1.0 = 100% for meeting that specific goal, so higher scores closer to 1.0 mean greater adherence to this Auditory Training program.

Outcome measures

Outcome measures
Measure	HA and CI Users Using the Audiobooks for Hearing Loss App as Auditory Training n=27 Participants Study participants will use the Audiobooks for HL App for 12 weeks using the App at least two hours per week on their own. The researcher will conduct 12 weekly visits where the following will be done: First 6 weeks: • Partial BKB-SIN will be administered Final 6 weeks: * Partial BKB-SIN will be administered * Conduct a comprehension test. * Address any usability issues the participant brings up. * Review and set new weekly goals Final session: Conduct Final Usability survey of the App
Audiobooks Adherence: Overall Mean Score of Weekly Goals Met for HA and CI Users Using the Audiobooks for HL App as an Auditory Training Program Minutes of listening, met goal of 2 hours	.9275 score on a scale Standard Error .1313
Audiobooks Adherence: Overall Mean Score of Weekly Goals Met for HA and CI Users Using the Audiobooks for HL App as an Auditory Training Program Minutes of Standard Speech, met goal	.9667 score on a scale Standard Error .0680
Audiobooks Adherence: Overall Mean Score of Weekly Goals Met for HA and CI Users Using the Audiobooks for HL App as an Auditory Training Program Minutes of Pure Listening, met goal	.9545 score on a scale Standard Error .0917
Audiobooks Adherence: Overall Mean Score of Weekly Goals Met for HA and CI Users Using the Audiobooks for HL App as an Auditory Training Program Minutes of not text support, met goal	.9420 score on a scale Standard Error .1190
Audiobooks Adherence: Overall Mean Score of Weekly Goals Met for HA and CI Users Using the Audiobooks for HL App as an Auditory Training Program Minutes of listening in background noise, met goal	.9815 score on a scale Standard Error .0539

Adverse Events

HA and CI Users Using the Audiobooks for Hearing Loss App as Auditory Training

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

K. Lindaas, Principal Investigator

BioSpeech

Phone: (503) 522-6276

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place