Trial Outcomes & Findings for The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study (NCT NCT02042404)

NCT ID: NCT02042404

Last Updated: 2016-02-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

Baseline and 30 days

Results posted on

2016-02-02

Participant Flow

Flyers approved by WIRB for subject recruitment. Also referrals from local audiology clinics and otologists.

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."

Participant milestones

Participant milestones
Measure	Primary Cohort: Mild to Severe Hearing Impairment 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: Mild to Severe Hearing Impairment Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Overall Study STARTED	43	5
Overall Study COMPLETED	38	5
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Primary Cohort: Mild to Severe Hearing Impairment 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: Mild to Severe Hearing Impairment Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Overall Study Death	1	0
Overall Study Unrelated Adverse Event	3	0
Overall Study Inability to meet time requirements	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mild to Severe Hearing Impairment n=48 Participants Subjects wearing the Earlens System in their daily lives.
Age, Continuous	68.6 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 30 days

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

Outcome measures

Outcome measures
Measure	Primary Cohort: Mild to Severe Hearing Impairment n=39 Participants 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: Mild to Severe Hearing Impairment Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.	37.6 percentage of words correctly identified Standard Deviation 24.6	—

PRIMARY outcome

Timeframe: Baseline and 120 days

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

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.

Outcome measures

Outcome measures
Measure	Primary Cohort: Mild to Severe Hearing Impairment n=43 Participants 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: Mild to Severe Hearing Impairment Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment	-0.3983 dB difference in Unaided Hearing Standard Deviation 2.9822	—

SECONDARY outcome

Timeframe: Baseline and 30 days

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

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.

Outcome measures

Outcome measures
Measure	Primary Cohort: Mild to Severe Hearing Impairment n=39 Participants 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: Mild to Severe Hearing Impairment Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Functional Gain Over the Frequency Range From 2000 to 10,000 Hz	30.4819 dB difference in Soundfield Hearing Standard Deviation 10.2504	—

SECONDARY outcome

Timeframe: Baseline and 30 days

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

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.

Outcome measures

Outcome measures
Measure	Primary Cohort: Mild to Severe Hearing Impairment n=39 Participants 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: Mild to Severe Hearing Impairment Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.	0.7542 dB difference in HINT scores Standard Deviation 4.2207	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 120 days

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

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.

Outcome measures

Outcome measures
Measure	Primary Cohort: Mild to Severe Hearing Impairment n=48 Participants 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: Mild to Severe Hearing Impairment Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
Determine the Incidence of Serious Device- and Procedure-related Adverse Events.	0 serious device- or procedure-related AEs	—

Adverse Events

Mild to Severe Hearing Impairment

Serious events: 5 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mild to Severe Hearing Impairment n=48 participants at risk Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
Psychiatric disorders Altered mental status	2.1% 1/48 • Number of events 1
Injury, poisoning and procedural complications Hospitalized for bike accident	2.1% 1/48 • Number of events 1
Psychiatric disorders Drug overdose leading to death	2.1% 1/48 • Number of events 1
Respiratory, thoracic and mediastinal disorders Bacterial pneumonia	2.1% 1/48 • Number of events 1
Cardiac disorders Hospitalized for heart issues	2.1% 1/48 • Number of events 1

Other adverse events

Other adverse events
Measure	Mild to Severe Hearing Impairment n=48 participants at risk Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
Ear and labyrinth disorders Abrasion/Blood blister in the ear canal	27.1% 13/48 • Number of events 17
Ear and labyrinth disorders Abrasion/Blood/Blister on tympanic membrane	4.2% 2/48 • Number of events 2
Ear and labyrinth disorders Ear discomfort/pain	10.4% 5/48 • Number of events 5
Ear and labyrinth disorders Ear tip, other: swelling, itching	4.2% 2/48 • Number of events 2
Ear and labyrinth disorders Inflammation/Granulation tissue on tympanic membrane	6.2% 3/48 • Number of events 3
Ear and labyrinth disorders Pain upon eructation/ valsalva	2.1% 1/48 • Number of events 1
Ear and labyrinth disorders Pressure sensation of device on tympanic membrane	2.1% 1/48 • Number of events 1

Additional Information

Dr. Suzanne Levy, Director of Clinical Research

EarLens Corporation

Phone: 650 366 9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place