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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 the proposed study (Extended Investigation under the Continued Access Policy) is to continue to allow access to the investigational medical device with the collection of device utility and clinic process-flow data while the marketing application is under review at the FDA.
The study is designed to obtain observational data and as such no primary safety or efficacy endpoints or sample sizes are computed. Information gathered about device utility and clinic procedures from the physician, audiologist as well as subject questionnaires will be analyzed for the purpose of optimizing the process flow in different types of practice settings. A subset of relevant safety and efficacy measures from the Definitive Study (DEN150002) will be collected and adverse events will be tracked and reported per applicable regulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sound amplificatoin via EarLens CHD | Experimental | Sound amplification provided via the EarLens CHD for subjects with hearing impairment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sound amplification provided via the EarLens CHD | Device | Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hearing Stability Using Unaided Air Conduction Thresholds. | Hearing sensitivity was monitored using earphones with the TMT (Tympanic Membrane Transducer) in place, but with the audio processor removed. Baseline and study end measurements were compared. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000 and 4000 Hz) was computed both for baseline unaided hearing post-placement with TMT in place, and unaided hearing with TMT in place at the 90-day for each ear, then averaged across both ears for each subject. A determination of "No Hearing Change" for the subject was made if the calculated hearing changes of the subject population are 10dB or less. | Baseline and up to 90-day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Speech Understanding in Noise. | The change in aided speech reception thresholds (SRTs) when compared to the baseline unaided condition was measured using a validated speech test, the HINT 90. Change in aided HINT 90 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and/or related to the investigational device or the procedure. | Baseline and up to 90-day. |
Inclusion Criteria:
Age 18 to 85 years.
Mild to severe hearing impairment between 125 to 8000 Hz.
Asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by MRI.
No significant conductive hearing impairment;
Greater than or equal to 50% on clinical speech discrimination demonstrating an ability to benefit from amplification;
Able and willing to commit to the travel and time demands of the study (available for 5 months or longer) and able to comprehend and comply with the study materials and instructions
Experience with 1 or 2 air conduction hearing aids or previously evaluated for use with hearing aids;
Fluent speaker of American English due to use of American English study materials
Exclusion Criteria:
The Subject must not have known or active medical issues that would preclude having a hearing device, including:
Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
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| Name | Affiliation | Role |
|---|---|---|
| Brent Edwards | EarLens, Corp. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Hearing and Balance Center | La Jolla | California | 92037 | United States | ||
| Rodney Perkins Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sound Amplification Via EarLens CHD | Sound amplification provided via the EarLens CHD for subjects with hearing impairment. Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sound Amplification Via EarLens CHD | Sound amplification provided via the EarLens CHD for subjects with hearing impairment. Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Hearing Stability Using Unaided Air Conduction Thresholds. | Hearing sensitivity was monitored using earphones with the TMT (Tympanic Membrane Transducer) in place, but with the audio processor removed. Baseline and study end measurements were compared. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000 and 4000 Hz) was computed both for baseline unaided hearing post-placement with TMT in place, and unaided hearing with TMT in place at the 90-day for each ear, then averaged across both ears for each subject. A determination of "No Hearing Change" for the subject was made if the calculated hearing changes of the subject population are 10dB or less. | 40 subjects available for analysis between enrollment and 90-day measurement. | Posted | Mean | Standard Deviation | dB difference in Unaided Hearing | Baseline and up to 90-day. |
|
90-days
Subjects fitted with the Earlens Hearing Aid Device were evaluated for Adverse Events through 90-day follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sound Amplification Via EarLens CHD | Sound amplification provided via the EarLens CHD for subjects with hearing impairment. Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abrasion/blood/blister on tympanic membrane | Ear and labyrinth disorders | Non-systematic Assessment | Device and/or procedure related, anticipated, mild, all resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suzanne Levy, Director of Clinical Research | Earlens Corporation | 650-739-4447 | Suzanne.Levy@Earlens.com |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Baseline and up to 90-day. |
| Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz. | 10 dB (decibel) change in the average pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield (SF) thresholds measured prior to device placement and the aided soundfield thresholds measured 90-day post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds | Baseline and up to 90-day. |
| Change in Subject's Self-Perceived Ability to Communicate. | The change in the subject's self-perceived ability to communicate with the use of the EarLens Device (CHD) when compared to baseline condition was measured using the validated Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV), which all range from 0-99%. A global score is computed by averaging the EC, RV, and BN subscores. For an individual score (either unaided alone or aided alone), a higher number indicates poorer performance, or more difficulty experienced. For this outcome measure, the difference between the average of the global unaided and aided scores is computed to determine the reduction (if any) in self-perceived difficulty, so a larger number in this outcome measure indicates better performance, as more of the difficulty has been reduced from the unaided condition by going to the aided condition. | Baseline and up to 90-day. |
| Menlo Park |
| California |
| 94025 |
| United States |
| Camino Ear Nose and Throat Clinic | San Jose | California | 95138 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| CNC Hearing and Balance Center | Marrero | Louisiana | 70072 | United States |
| Carolina Ear and Hearing Clinic | Raleigh | North Carolina | 27609 | United States |
| Pittsburgh Ear Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| Ear Medical Group | San Antonio | Texas | 78240 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
|
|
| Secondary | Change in Speech Understanding in Noise. | The change in aided speech reception thresholds (SRTs) when compared to the baseline unaided condition was measured using a validated speech test, the HINT 90. Change in aided HINT 90 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. | 28 subjects available for analysis between enrollment/treatment and 90-day measurement. | Posted | Mean | Standard Deviation | dB difference in HINT scores | Baseline and up to 90-day. |
|
|
|
| Secondary | Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz. | 10 dB (decibel) change in the average pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield (SF) thresholds measured prior to device placement and the aided soundfield thresholds measured 90-day post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds | 40 subjects available for analysis between enrollment/treatment and 90-day measurement. | Posted | Mean | Standard Deviation | dB difference in SF Hearing Thresholds | Baseline and up to 90-day. |
|
|
|
| Secondary | Change in Subject's Self-Perceived Ability to Communicate. | The change in the subject's self-perceived ability to communicate with the use of the EarLens Device (CHD) when compared to baseline condition was measured using the validated Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV), which all range from 0-99%. A global score is computed by averaging the EC, RV, and BN subscores. For an individual score (either unaided alone or aided alone), a higher number indicates poorer performance, or more difficulty experienced. For this outcome measure, the difference between the average of the global unaided and aided scores is computed to determine the reduction (if any) in self-perceived difficulty, so a larger number in this outcome measure indicates better performance, as more of the difficulty has been reduced from the unaided condition by going to the aided condition. | 40 subjects available for analysis between enrollment/treatment and 90-day measurement. | Posted | Mean | Standard Deviation | percentage of perceived benefit | Baseline and up to 90-day. |
|
|
|
| Other Pre-specified | Adverse Events | All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and/or related to the investigational device or the procedure. | Posted | Count of Participants | Participants | Baseline and up to 90-day. |
|
|
|
| 0 |
| 46 |
| 34 |
| 46 |
|
| Abrasion/blood/blister in ear canal | Ear and labyrinth disorders | Non-systematic Assessment | Device and/or procedure related, anticipated, mild/ moderate, all resolved. |
|
| Ear discomfort/pain | Ear and labyrinth disorders | Non-systematic Assessment | Device and/or procedure related, anticipated, mild/moderate, all resolved or improved. |
|
| Ear tip, other: swelling, itching | Ear and labyrinth disorders | Non-systematic Assessment | Device and/or procedure related, anticipated, mild, all resolved. |
|
| Inflammation/granulation tissue on TM | Ear and labyrinth disorders | Non-systematic Assessment | Device and/or procedure related, anticipated, mild, all resolved. |
|
| External otitis | Ear and labyrinth disorders | Non-systematic Assessment | Device and/or procedure related, anticipated, mild, all resolved. |
|
| TM perforation | Ear and labyrinth disorders | Non-systematic Assessment | Device and/or procedure related, anticipated, moderate, all resolved. |
|
| Claustrophobia sensation | Ear and labyrinth disorders | Non-systematic Assessment | Device and/or procedure related, anticipated, moderate, all resolved. |
|
| Other: Erythemia-pinpoint; or Petechia | Ear and labyrinth disorders | Non-systematic Assessment | Device and/or procedure related, anticipated, mild, all resolved. |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Ear tip, other: swelling, itching |
|
| Inflammation/granulation tissue on TM |
|
| External otitis |
|
| TM perforation |
|
| Claustrophobia sensation |
|
| Other: Petechia and Erythemia |
|