Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild to severe hearing impairment | Experimental | Sound amplification provided via the EarLens System assistive hearing device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sound amplification provided via EarLens System. | Device | 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 | Description | Time Frame |
|---|---|---|
| Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition. | 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. | Baseline and 30 days |
| Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment | 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. | Baseline and 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Gain Over the Frequency Range From 2000 to 10,000 Hz | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Incidence of Serious Device- and Procedure-related Adverse Events. | 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. | 120 days |
Inclusion Criteria:
Exclusion Criteria:
Must not have known or active medical issues that would preclude having a device including:
Must not have other known or active medical issues including:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bruce Gantz, M.D. | University of Iowa Dept of Otolaryngology--Head and Neck Surgery University of Iowa Hospitals and Clinics | Principal Investigator |
| Sunil Puria, Ph.D. | EarLens Corp. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EarLens Corporation | Menlo Park | California | 94025 | United States | ||
| Camino Ear Nose and Throat Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23524632 | Background | 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. | |
| 30300158 | Derived | Arbogast TL, Moore BCJ, Puria S, Dundas D, Brimacombe J, Edwards B, Carr Levy S. Achieved Gain and Subjective Outcomes for a Wide-Bandwidth Contact Hearing Aid Fitted Using CAM2. Ear Hear. 2019 May/Jun;40(3):741-756. doi: 10.1097/AUD.0000000000000661. |
| Label | URL |
|---|---|
| EarLens Corporation website | View source |
Not provided
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."
Flyers approved by WIRB for subject recruitment. Also referrals from local audiology clinics and otologists.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Roll-in Cohort: Mild to Severe Hearing Impairment | Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Both Primary Cohort and Roll-in Cohorts combined in Demographic Report
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mild to Severe Hearing Impairment | Subjects wearing the Earlens System in their daily lives. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition. | 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. | 39 subjects available for analysis between enrollment/treatment and 30 day measurement. | Posted | Mean | Standard Deviation | percentage of words correctly identified | Baseline and 30 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mild to Severe Hearing Impairment | Both Primary Cohort and Roll-in Cohorts are combined for safety analysis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered mental status | Psychiatric disorders | Not device related. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abrasion/Blood blister in the ear canal | Ear and labyrinth disorders | Device related, anticipated, mild, all resolved. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suzanne Levy, Director of Clinical Research | EarLens Corporation | 650 366 9000 | slevy@earlenscorp.com |
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline and 30 days |
| Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition. | 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. | Baseline and 30 days |
| San Jose |
| California |
| 95138 |
| United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Inability to meet time requirements |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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. |
| OG001 | Roll-in Cohort: Mild to Severe Hearing Impairment | Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation. |
|
|
|
| Primary | Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment | 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. | 43 subjects available for analysis between enrollment/treatment and 120 day measurement. | Posted | Mean | Standard Deviation | dB difference in Unaided Hearing | Baseline and 120 days |
|
|
|
|
| Secondary | Functional Gain Over the Frequency Range From 2000 to 10,000 Hz | 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. | 39 subjects available for analysis between enrollment/treatment and 30 day measurement. | Posted | Mean | Standard Deviation | dB difference in Soundfield Hearing | Baseline and 30 days |
|
|
|
|
| Secondary | Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition. | 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. | 39 subjects available for analysis between enrollment/treatment and 30 day measurement. | Posted | Mean | Standard Deviation | dB difference in HINT scores | Baseline and 30 days |
|
|
|
|
| Other Pre-specified | Determine the Incidence of Serious Device- and Procedure-related Adverse Events. | 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. | Both Primary Cohort and Roll-in Cohort were included in all safety analyses. | Posted | Number | serious device- or procedure-related AEs | 120 days |
|
|
|
| 5 |
| 48 |
| 25 |
| 48 |
| Hospitalized for bike accident | Injury, poisoning and procedural complications | Not device related. |
|
| Drug overdose leading to death | Psychiatric disorders | Not device related. |
|
| Bacterial pneumonia | Respiratory, thoracic and mediastinal disorders | Not device related. |
|
| Hospitalized for heart issues | Cardiac disorders | Not device related. |
|
|
| Abrasion/Blood/Blister on tympanic membrane | Ear and labyrinth disorders | Device related, anticipated, mild, all resolved. |
|
| Ear discomfort/pain | Ear and labyrinth disorders | Device related, anticipated, mild/moderate, all resolved. |
|
| Ear tip, other: swelling, itching | Ear and labyrinth disorders | Device related, anticipated, mild/moderate, all resolved. |
|
| Inflammation/Granulation tissue on tympanic membrane | Ear and labyrinth disorders | Device related, anticipated, mild, all resolved. |
|
| Pain upon eructation/ valsalva | Ear and labyrinth disorders | Device related, anticipated, mild, all resolved. |
|
| Pressure sensation of device on tympanic membrane | Ear and labyrinth disorders | Device related, anticipated, mild, ongoing as subject continues to wear the device.. |
|
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |