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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sound amplification provided via EarLens System.

About this trial

This is an interventional treatment trial for Hearing Impairment focused on measuring Hearing impairment, Hearing loss

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

EarLens Corporation
Camino Ear Nose and Throat Clinic
University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mild to severe hearing impairment

Arm Description

Sound amplification provided via the EarLens System assistive hearing device.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02042404

First Posted

January 20, 2014

Last Updated

January 4, 2016

Sponsor

EarLens Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02042404

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EarLens Corporation

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Impairment

Keywords

Hearing impairment, Hearing loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild to severe hearing impairment

Arm Type

Experimental

Arm Description

Sound amplification provided via the EarLens System assistive hearing device.

Intervention Type

Device

Intervention Name(s)

Sound amplification provided via EarLens System.

Intervention Description

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.

Primary Outcome Measure Information:

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

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

Secondary Outcome Measure Information:

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

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

Other Pre-specified Outcome Measures:

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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: an abnormal tympanic membrane an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes 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: history of chronic and recurrent ear infections in the past 24 mouths history of dizziness and/or vertigo in the past 24 months taking medications/treatments with known ototoxic effects a rapidly progressive or fluctuating hearing impairment 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Gantz, M.D.

Organizational Affiliation

University of Iowa Dept of Otolaryngology--Head and Neck Surgery University of Iowa Hospitals and Clinics

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sunil Puria, Ph.D.

Organizational Affiliation

EarLens Corp.

Official's Role

Study Chair

Facility Information:

Facility Name

EarLens Corporation

City

Menlo Park

State/Province

California

ZIP/Postal Code

94025

Country

United States

Facility Name

Camino Ear Nose and Throat Clinic

City

San Jose

State/Province

California

ZIP/Postal Code

95138

Country

United States

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23524632

Citation

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.

Results Reference

background

PubMed Identifier

30300158

Citation

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.

Results Reference

derived

Links:

URL

http://www.earlenscorp.com

Description

EarLens Corporation website

Hearing Impairment

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial