Trial Outcomes & Findings for A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid (NCT NCT03086018)

Last Updated: 2019-11-06

Results Overview

Speech test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the current device, and aided with the new device. The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 dB and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.

Results posted on

2019-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Successor Hearing Aid to Juna The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
Field Testing STARTED	30
Field Testing COMPLETED	30
Field Testing NOT COMPLETED	0
Final Testing for End of Trial STARTED	30
Final Testing for End of Trial COMPLETED	28
Final Testing for End of Trial NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Successor Hearing Aid to Juna The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
Final Testing for End of Trial Adverse Event	1
Final Testing for End of Trial Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Successor Hearing Aid to Juna n=30 Participants The intervention is the new hearing aid which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
Age, Continuous	67 years n=30 Participants
Sex: Female, Male Female	6 Participants n=30 Participants
Sex: Female, Male Male	24 Participants n=30 Participants
Region of Enrollment Switzerland	30 participants n=30 Participants
Hearing Instrument Experience	30 Participants n=30 Participants

PRIMARY outcome

Timeframe: 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.

Outcome measures

Outcome measures
Measure	Experimental: Successor Hearing Aid to Juna n=28 Participants The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
Speech Intelligibility Performance Unaided	-1.25 dB SNR Standard Deviation 1.45
Speech Intelligibility Performance Aided with current device	-3.89 dB SNR Standard Deviation 0.99
Speech Intelligibility Performance Adided with new device	-5.22 dB SNR Standard Deviation 1.09

SECONDARY outcome

Timeframe: A 2 week time period during which they will wear the devices and answer questionnaires about the experience.

Population: For this questionnaire, two participants had left the study and data was not collected.

The subjective performance for the new device will be measured with the APHAB questionnaire (Abbreviated Hearing Aid Benefit Profile). The questionnaire is a list of 24 statement that the subjects must agree or disagree with using a scale of units from A to G (A being Always and G being Never). Each letter has a corresponding score used for the calculation: A receives 99, B receives 87, C receives 75, D receives 50, E receives 25, F recevies 12, and G receives 1. An average for each subscale is calculated, and a global or overall score can be calculated by taking the mean of the three positive subscales (Ease of communication, Background noise, and Reverberation). For these three subscales a higher score indicates a better performance. The highest possible score is 99 and the lowest is 1. The fourth scale (Aversiveness) is a negative scale meaning that a higher score means a worse performance. The highest possible score is 99 and the lowest is 1.

Outcome measures

Outcome measures
Measure	Experimental: Successor Hearing Aid to Juna n=28 Participants The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
Subjective Performance of Aided Benefit Ease of Communication	37.38 Units on a scale Standard Deviation 24.11
Subjective Performance of Aided Benefit Background Noise	44.29 Units on a scale Standard Deviation 16.89
Subjective Performance of Aided Benefit Reverberation	42.08 Units on a scale Standard Deviation 23.96
Subjective Performance of Aided Benefit Aversiveness	-17.63 Units on a scale Standard Deviation 26.14
Subjective Performance of Aided Benefit Global Score	40.30 Units on a scale Standard Deviation 20.49

SECONDARY outcome

Timeframe: 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.

Word recognition test scores will be measured with two signal-to-noise ratio (SNR) levels in percent correct in two conditions, with the new feature on and the new feature off. The test is a speech test with the words stated in noise at either a 5 dB SNR or a 15 dB SNR. The subject is presented with 5 rhyming words and must choose which word they heard. It is a forced choice meaning that the test will not continue with the next word until they've made a selection. They cannot leave any blank and are not penalized for wrong answers. The score is a percentage of words correct with the maximum score being 100% and the minimum being 0%. A higher score means a better outcome.

Outcome measures

Outcome measures
Measure	Experimental: Successor Hearing Aid to Juna n=30 Participants The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
Speech Intelligibility Performance With New Feature +5 SNR WAKO Feature on	73.5 percent correct out of 100% Standard Deviation 5.2
Speech Intelligibility Performance With New Feature +5 SNR WAKO Feature off	73.7 percent correct out of 100% Standard Deviation 4.95
Speech Intelligibility Performance With New Feature +15 SNR WAKO Feature on	87.27 percent correct out of 100% Standard Deviation 4.08
Speech Intelligibility Performance With New Feature +15 SNR WAKO Feature off	88.1 percent correct out of 100% Standard Deviation 4.63

SECONDARY outcome

Timeframe: 2 hour period of usability testing with tasks and questionnaires.

The usability of the new device will be measured with a 3-point rating scale used by the tester to evaluate tasks performed by the end user as well as questionnaires and interviews. The questionnaire asks subjects to perform tasks, and the clinician rates the ease with which they complete the tasks. 2 is the highest score meaning that they could complete without help, 1 means that they required some assistance, and 0 means that they could not complete the task. A higher score means a better outcome.

Outcome measures

Outcome measures
Measure	Experimental: Successor Hearing Aid to Juna n=30 Participants The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
Handling/Usability Performance	97 percentage of tasks scored with 2

SECONDARY outcome

Timeframe: A 2 hour period of interviews and questionnaires after having worn the devices for approximately 2 weeks and keeping a diary to make notes of device behavior.

Events will be measured by the reporting of unexpected sounds or behavior of the device through questionnaires, diaries, and interviews. The number of events reported including AEs related to the device will be used to measure the outcome. Less events is a better outcome.

Outcome measures

Outcome measures
Measure	Experimental: Successor Hearing Aid to Juna n=30 Participants The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
Events	4 Units of AEs related to device

Adverse Events

Experimental: Successor Hearing Aid to Juna

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Successor Hearing Aid to Juna n=30 participants at risk The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
Social circumstances Hospitalization due to accident	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.

Other adverse events

Other adverse events
Measure	Experimental: Successor Hearing Aid to Juna n=30 participants at risk The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks.
General disorders Cold	6.7% 2/30 • Number of events 3 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
General disorders Tore Meniscus	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
General disorders Scratch on ear canal	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
Product Issues Dome in Ear	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
General disorders Headache	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
General disorders Irritation in ear	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
Product Issues Sore Concha	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
General disorders Back Pain	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
General disorders Pressure point	3.3% 1/30 • Number of events 2 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
General disorders Tore Groin muscle	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
General disorders Leg problem	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
General disorders Face Swelling	3.3% 1/30 • Number of events 1 • 4 months All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.

Additional Information

Julie Tantau

Bernafon AG

Phone: +41 31 998 1646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place