A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid

• Sponsor: Bernafon AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03086018
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the performance of the hearing aid under laboratory as well as everyday conditions. In addition, the performance data of the hearing aid are compared with a Bernafon hearing aid already available on the market.

The hearing aids are adapted according to the user requirements. The data collected in the study is intended to show that the benefit of the hearing aid being examined is identical or better than the current CE-marked hearing aid. A further aim is to improve the adaptation of the hearing device in such a way that the benefit for people with hearing impairments can be increased.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss	Device: Successor hearing aid to Juna	N/A

Detailed Description

The reason for this study is to evaluate a new hearing aid. The goal is to evaluate the audiological performance and usability as well as features and functions in comparison to the hearing aid already CE marked. Furthermore, it is important to identify unexpected or unwanted behavior from the devices. This clinical investigation is a validation testing and is designed to evaluate the new hearing instrument system. As human subjects are involved, this validation test falls under the definition of a clinical investigation. The validation addresses the performance of the device with new functionality, and additionally addresses whether the end user can understand speech as well as with the current marketed device.

End users will be tested in the lab with speech tests and usability tests. They will also participate in field tests after which they will answer questionnaires concerning their experience with the instruments. Evaluating the overall performance of the hearing instrument is important to verify that the end user is satisfied with the device and that all user requirements are fulfilled. Many of the features available in the new device have already been validated and are used in devices currently on the market.

The purpose of this research is to show that the performance of the new device is as good as or better than the current device. Furthermore, speech should not be negatively affected with the addition of new features, the usability of the devices (that end users are able to handle the devices) should be as good as the current device, and there should be no artifacts or unwanted noises. Some measurements serve as quality control prior to product launch.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A single group, controlled test design will be used. There are various aspects of testing including lab and field tests.A single group, controlled test design will be used. There are various aspects of testing including lab and field tests.
• Masking: None (Open Label)
• Masking Description: The hardware will be obviously different from the control devices and impossible to blind.
• Primary Purpose: Treatment
• Official Title: A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid in Comparison to the Currently Marketed Device
• Actual Study Start Date: Mar 13, 2017
• Actual Primary Completion Date: Jun 28, 2017
• Actual Study Completion Date: Jun 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
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. The will wear the intervention device for approximately two weeks.	Device: Successor hearing aid to Juna; The participants will all be experienced hearing instrument device users and will be switched from their current (control) devices to the new test device which succeeds the Juna device.

Outcome Measures

Primary Outcome Measures

1. Speech Intelligibility Performance [2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.]

   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.

Secondary Outcome Measures

1. Subjective Performance of Aided Benefit [A 2 week time period during which they will wear the devices and answer questionnaires about the experience.]

   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.

2. Speech Intelligibility Performance With New Feature [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.

3. Handling/Usability Performance [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.

4. Events [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All classifications of hearing loss (sensorineural, conductive, mixed)

• If the hearing loss is conductive or mixed it must be approved for amplification by a physician

• All shapes of hearing loss (flat, sloping, reverse slope, notch)

• Severity ranging from mild to severe

• German speaking

• Ability and willingness to sign the consent form

Exclusion Criteria:

• Contraindications for amplification

• Active ear disease

• Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant,

• A reduced mobility making them unable to attend weekly study appointments

• A reduced ability to describe auditory impressions and the usage of the hearing aids

• Uncooperative so that it is not possible to record a valid pure tone audiogram

• A strongly reduced dexterity

• Central hearing disorders

• Bernafon employees

• Family members of Bernafon employees

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bernafon AG	Bern		Switzerland	3018

Sponsors and Collaborators

• Bernafon AG

Investigators

• Principal Investigator: Barbara Simon, AuD, Bernafon AG

Study Documents (Full-Text)

• Study Protocol - Jan 2, 2017
• Statistical Analysis Plan - Nov 14, 2016

More Information

Publications

None provided.

• Responsible Party: Bernafon AG
• ClinicalTrials.gov Identifier: NCT03086018
• Other Study ID Numbers: BF001-1611
• First Posted: Mar 22, 2017
• Last Update Posted: Nov 6, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hearing Loss

Study Results

Participant Flow

Arm/Group Title	Experimental: Successor Hearing Aid to Juna
Arm/Group Description	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.
Period Title: Field Testing
STARTED	30
COMPLETED	30
NOT COMPLETED	0
Period Title: Field Testing
STARTED	30
COMPLETED	28
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Experimental: Successor Hearing Aid to Juna
Arm/Group Description	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.
Overall Participants	30
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	67
Sex: Female, Male (Count of Participants)
Female	6 20%
Male	24 80%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Switzerland	30 100%
Hearing Instrument Experience (Count of Participants)
Count of Participants [Participants]	30 100%

Outcome Measures

1. Primary Outcome

Title	Speech Intelligibility Performance
Description	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.
Time Frame	2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Successor Hearing Aid to Juna
Arm/Group Description	The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. The will wear the intervention device for approximately two weeks. Successor hearing aid to Juna: The participants will all be experienced hearing instrument device users and will be switched from their current (control) devices to the new test device which succeeds the Juna device.
Measure Participants	28
Unaided	-1.25 (1.45)
Aided with current device	-3.89 (0.99)
Adided with new device	-5.22 (1.09)

2. Secondary Outcome

Title	Subjective Performance of Aided Benefit
Description	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.
Time Frame	A 2 week time period during which they will wear the devices and answer questionnaires about the experience.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Experimental: Successor Hearing Aid to Juna
Arm/Group Description	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.
Measure Participants	28
Ease of Communication	37.38 (24.11)
Background Noise	44.29 (16.89)
Reverberation	42.08 (23.96)
Aversiveness	-17.63 (26.14)
Global Score	40.30 (20.49)

3. Secondary Outcome

Title	Speech Intelligibility Performance With New Feature
Description	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.
Time Frame	2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: Successor Hearing Aid to Juna
Arm/Group Description	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.
Measure Participants	30
+5 SNR WAKO Feature on	73.5 (5.2)
+5 SNR WAKO Feature off	73.7 (4.95)
+15 SNR WAKO Feature on	87.27 (4.08)
+15 SNR WAKO Feature off	88.1 (4.63)

4. Secondary Outcome

Title	Handling/Usability Performance
Description	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.
Time Frame	2 hour period of usability testing with tasks and questionnaires.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: Successor Hearing Aid to Juna
Arm/Group Description	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.
Measure Participants	30
Number [percentage of tasks scored with 2]	97

5. Secondary Outcome

Title	Events
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental: Succssor Hearing Aid to Juna
Arm/Group Description	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.
Measure Participants	30
Number [Units of AEs related to device]	4

Adverse Events

Time Frame	4 months
Adverse Event Reporting Description	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.
Arm/Group Title	Experimental: Successor Hearing Aid to Juna
Arm/Group Description	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.
All Cause Mortality
	Experimental: Successor Hearing Aid to Juna
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Experimental: Successor Hearing Aid to Juna
	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)
Social circumstances
Hospitalization due to accident	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	Experimental: Successor Hearing Aid to Juna
	Affected / at Risk (%)	# Events
Total	11/30 (36.7%)
General disorders
Cold	2/30 (6.7%)	3
Tore Meniscus	1/30 (3.3%)	1
Scratch on ear canal	1/30 (3.3%)	1
Headache	1/30 (3.3%)	1
Irritation in ear	1/30 (3.3%)	1
Back Pain	1/30 (3.3%)	1
Pressure point	1/30 (3.3%)	2
Tore Groin muscle	1/30 (3.3%)	1
Leg problem	1/30 (3.3%)	1
Face Swelling	1/30 (3.3%)	1
Product Issues
Dome in Ear	1/30 (3.3%)	1
Sore Concha	1/30 (3.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.