The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study

• Sponsor: EarLens Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02042404
• Collaborator: (none)
• Enrollment: 48
• Locations: 3
• Arm: 1
• Duration (Months): 12
• Patients Per Site: 16
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The EarLens System is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. The purpose of this multi-center definitive study is to assess the safety and efficacy of the EarLens System for subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully activated system in their daily lives for a 4 month period of time. This study is designed to support US and International marketing applications to commercialize the EarLens System. The main efficacy hypothesis is that the EarLens System will be shown to improve speech understanding in quiet.

Condition or Disease	Intervention/Treatment	Phase
Hearing Impairment	Device: Sound amplification provided via EarLens System.	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Mild to severe hearing impairment Sound amplification provided via the EarLens System assistive hearing device.

Device: Sound amplification provided via EarLens System.; The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.

Outcome Measures

Primary Outcome Measures

1. Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition. [Baseline and 30 days]

   Change in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. WRS will be measured using 50-word NU-6 (Northwestern University Auditory Test No.6) recorded materials, presented at 45 dB Hearing Level on a per-ear basis with the test ear isolated for measurement and the results, expressed as a percentage of words correct, averaged across the two ears for each subject. All subject data will then be averaged to obtain the means. The baseline unaided measurements will occur prior to device placement, and the aided condition will be measured at least 30 days post device placement.

2. Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment [Baseline and 120 days]

   The unaided air conduction hearing thresholds will be measured for each individual ear twice before device placement at Visit #1 and averaged to obtain the baseline unaided air conduction hearing thresholds, and the post wear unaided air conduction hearing thresholds will be measured after device removal at Visit #5. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal for each ear, then averaged across both ears for each subject . A determination of "No Hearing Change" for the subject population will be made if the calculated Hearing Changes of the subject population are 10 dB or less.

Secondary Outcome Measures

1. Functional Gain Over the Frequency Range From 2000 to 10,000 Hz [Baseline and 30 days]

   10 dB (decibel) change in the averaged pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, 9000 and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield thresholds measured prior to device placement and the aided soundfield thresholds measured at least 30 days post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds.

2. Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition. [Baseline and 30 days]

   Change in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means. Analysis includes calculation of the unaided measurements (before device placement) minus the aided measurements.

Other Outcome Measures

1. Determine the Incidence of Serious Device- and Procedure-related Adverse Events. [120 days]

   The analysis of the incidence of serious device- and procedure-related adverse events through the study period. All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are related to the investigational device.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 to 85 years

• Mild to severe hearing impairment between 125 to 4000 Hz

• No significant conductive hearing impairment

• Able and willing to commit to travel and time demands of the study

Exclusion Criteria:

• Must not have known or active medical issues that would preclude having a device including:

1. an abnormal tympanic membrane

2. an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes

3. an ear canal anatomy that prevents physicians from seeing adequate amount of the tympanic membrane

• Must not have other known or active medical issues including:

1. history of chronic and recurrent ear infections in the past 24 mouths

2. history of dizziness and/or vertigo in the past 24 months

3. taking medications/treatments with known ototoxic effects

4. a rapidly progressive or fluctuating hearing impairment

5. having been diagnosed with having a compromised immune system

• Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56

• Must not have an ear canal anatomy that preclude manufacture of the device as determined by EarLens manufacturing personnel

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EarLens Corporation	Menlo Park	California	United States	94025
2	Camino Ear Nose and Throat Clinic	San Jose	California	United States	95138
3	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• EarLens Corporation

Investigators

• Principal Investigator: Bruce Gantz, M.D., University of Iowa Dept of Otolaryngology--Head and Neck Surgery University of Iowa Hospitals and Clinics
• Study Chair: Sunil Puria, Ph.D., EarLens Corp.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• EarLens Corporation website

Publications

• Fay JP, Perkins R, Levy SC, Nilsson M, Puria S. Preliminary evaluation of a light-based contact hearing device for the hearing impaired. Otol Neurotol. 2013 Jul;34(5):912-21. doi: 10.1097/MAO.0b013e31827de4b1.

• Responsible Party: EarLens Corporation
• ClinicalTrials.gov Identifier: NCT02042404
• Other Study ID Numbers: EarLens CRP00004
• First Posted: Jan 22, 2014
• Last Update Posted: Feb 2, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by EarLens Corporation: Hearing impairment; Hearing loss
• Additional relevant MeSH terms: Hearing Loss; Deafness

Study Results

Participant Flow

Recruitment Details	Flyers approved by WIRB for subject recruitment. Also referrals from local audiology clinics and otologists.
Pre-assignment Detail	The first five (5) enrolled will be part of a pilot phase of the study to work out the process flow and training of the centers and participants, called "Roll-in Cohort."

Arm/Group Title	Primary Cohort: Mild to Severe Hearing Impairment	Roll-in Cohort: Mild to Severe Hearing Impairment
Arm/Group Description	Sound amplification provided via the EarLens System assistive hearing device. Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.	Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Period Title: Overall Study
STARTED	43	5
COMPLETED	38	5
NOT COMPLETED	5	0

Baseline Characteristics

Arm/Group Title	Mild to Severe Hearing Impairment
Arm/Group Description	Subjects wearing the Earlens System in their daily lives.
Overall Participants	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.6 (10.1)
Sex: Female, Male (Count of Participants)
Female	19 39.6%
Male	29 60.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.1%
Not Hispanic or Latino	47 97.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 6.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 4.2%
White	43 89.6%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.
Description	Change in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. WRS will be measured using 50-word NU-6 (Northwestern University Auditory Test No.6) recorded materials, presented at 45 dB Hearing Level on a per-ear basis with the test ear isolated for measurement and the results, expressed as a percentage of words correct, averaged across the two ears for each subject. All subject data will then be averaged to obtain the means. The baseline unaided measurements will occur prior to device placement, and the aided condition will be measured at least 30 days post device placement.
Time Frame	Baseline and 30 days

Outcome Measure Data

Analysis Population Description

39 subjects available for analysis between enrollment/treatment and 30 day measurement.

Arm/Group Title	Primary Cohort: Mild to Severe Hearing Impairment	Roll-in Cohort: Mild to Severe Hearing Impairment
Arm/Group Description	Sound amplification provided via the EarLens System assistive hearing device. Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.	Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Measure Participants	39	0
Mean (Standard Deviation) [percentage of words correctly identified]	37.6 (24.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary Cohort: Mild to Severe Hearing Impairment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	repeated measures ANOVA
	Comments

2. Primary Outcome

Title	Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment
Description	The unaided air conduction hearing thresholds will be measured for each individual ear twice before device placement at Visit #1 and averaged to obtain the baseline unaided air conduction hearing thresholds, and the post wear unaided air conduction hearing thresholds will be measured after device removal at Visit #5. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal for each ear, then averaged across both ears for each subject . A determination of "No Hearing Change" for the subject population will be made if the calculated Hearing Changes of the subject population are 10 dB or less.
Time Frame	Baseline and 120 days

Outcome Measure Data

Analysis Population Description

43 subjects available for analysis between enrollment/treatment and 120 day measurement.

Arm/Group Title	Mild to Severe Hearing Impairment
Arm/Group Description	Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
Measure Participants	43
Mean (Standard Deviation) [dB difference in Unaided Hearing]	-0.3983 (2.9822)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary Cohort: Mild to Severe Hearing Impairment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	repeated measures ANOVA
	Comments

3. Secondary Outcome

Title	Functional Gain Over the Frequency Range From 2000 to 10,000 Hz
Description	10 dB (decibel) change in the averaged pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, 9000 and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield thresholds measured prior to device placement and the aided soundfield thresholds measured at least 30 days post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds.
Time Frame	Baseline and 30 days

Outcome Measure Data

Analysis Population Description

39 subjects available for analysis between enrollment/treatment and 30 day measurement.

Arm/Group Title	Primary Cohort: Mild to Severe Hearing Impairment	Roll-in Cohort: Mild to Severe Hearing Impairment
Arm/Group Description	Sound amplification provided via the EarLens System assistive hearing device. Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.	Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Measure Participants	39	0
Mean (Standard Deviation) [dB difference in Soundfield Hearing]	30.4819 (10.2504)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary Cohort: Mild to Severe Hearing Impairment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	repeated measures ANOVA
	Comments

4. Secondary Outcome

Title	Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.
Description	Change in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means. Analysis includes calculation of the unaided measurements (before device placement) minus the aided measurements.
Time Frame	Baseline and 30 days

Outcome Measure Data

Analysis Population Description

39 subjects available for analysis between enrollment/treatment and 30 day measurement.

Arm/Group Title	Primary Cohort: Mild to Severe Hearing Impairment	Roll-in Cohort: Mild to Severe Hearing Impairment
Arm/Group Description	Sound amplification provided via the EarLens System assistive hearing device. Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.	Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Measure Participants	39	0
Mean (Standard Deviation) [dB difference in HINT scores]	0.7542 (4.2207)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primary Cohort: Mild to Severe Hearing Impairment
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0281
	Comments
	Method	repeated measures ANOVA
	Comments

5. Other Pre-specified Outcome

Title	Determine the Incidence of Serious Device- and Procedure-related Adverse Events.
Description	The analysis of the incidence of serious device- and procedure-related adverse events through the study period. All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are related to the investigational device.
Time Frame	120 days

Outcome Measure Data

Analysis Population Description

Both Primary Cohort and Roll-in Cohort were included in all safety analyses.

Arm/Group Title	Mild to Severe Hearing Impairment
Arm/Group Description	Sound amplification provided via the EarLens System assistive hearing device. Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.
Measure Participants	48
Number [serious device- or procedure-related AEs]	0

Adverse Events

Arm/Group Title	Mild to Severe Hearing Impairment
Arm/Group Description	Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
All Cause Mortality
	Mild to Severe Hearing Impairment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Mild to Severe Hearing Impairment
	Affected / at Risk (%)	# Events
Total	5/48 (10.4%)
Cardiac disorders
Hospitalized for heart issues	1/48 (2.1%)	1
Injury, poisoning and procedural complications
Hospitalized for bike accident	1/48 (2.1%)	1
Psychiatric disorders
Altered mental status	1/48 (2.1%)	1
Drug overdose leading to death	1/48 (2.1%)	1
Respiratory, thoracic and mediastinal disorders
Bacterial pneumonia	1/48 (2.1%)	1
Other (Not Including Serious) Adverse Events
	Mild to Severe Hearing Impairment
	Affected / at Risk (%)	# Events
Total	25/48 (52.1%)
Ear and labyrinth disorders
Abrasion/Blood blister in the ear canal	13/48 (27.1%)	17
Abrasion/Blood/Blister on tympanic membrane	2/48 (4.2%)	2
Ear discomfort/pain	5/48 (10.4%)	5
Ear tip, other: swelling, itching	2/48 (4.2%)	2
Inflammation/Granulation tissue on tympanic membrane	3/48 (6.3%)	3
Pain upon eructation/ valsalva	1/48 (2.1%)	1
Pressure sensation of device on tympanic membrane	1/48 (2.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.