Hearing ImpairmentNCT02042404
The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
A study testing Sound amplification provided via EarLens System. in people with Hearing Impairment, run by EarLens Corporation at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- Sound amplification provided via EarLens System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
EarLens Corporation
Menlo Park, California, 94025
Camino Ear Nose and Throat Clinic
San Jose, California, 95138
About this study
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.
- Conditions
- Hearing Impairment
- Being tested
- Sound amplification provided via EarLens System.
- Keywords
- Hearing impairment, Hearing loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Mild to severe hearing impairment | Experimental | Sound amplification provided via the EarLens System assistive hearing device. Receives: Device: Sound amplification provided via EarLens System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 120 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- EarLens Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Gantz, M.D., Principal investigator, University of Iowa Dept of Otolaryngology--Head and Neck Surgery University of Iowa Hospitals and ClinicsSunil Puria, Ph.D., Study chair, EarLens Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042404
- Sponsor's protocol ID
- EarLens CRP00004
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2014
- Last updated
- 2 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 23524632Arbogast 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.
PubMed 30300158
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
- ClinicalTrials.gov ID
- NCT02042404
- Acronym / sponsor ID
- EarLens CRP00004
- Conditions
- Hearing Impairment
- Keywords
- Hearing impairment, Hearing loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- EarLens CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Posted 2 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild to severe hearing impairment | Experimental | Device: Sound amplification provided via EarLens System.Sound amplification provided via the EarLens System assistive hearing device. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Mild to severe hearing impairment |
Primary outcome
Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.
Time frame: 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.
Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment
Time frame: 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.
2 secondary outcomes
Functional Gain Over the Frequency Range From 2000 to 10,000 Hz
Time frame: Baseline and 30 days
Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.
Time frame: Baseline and 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23524632Fay 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.
- Derived from this study: PubMed 30300158Arbogast 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.
- EarLens Corporation websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Gantz, M.D. principal investigator
University of Iowa Dept of Otolaryngology--Head and Neck Surgery University of Iowa Hospitals and Clinics
Sunil Puria, Ph.D. study chair
EarLens Corp.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound amplification provided via EarLens System. in people with Hearing Impairment, run by EarLens Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition. (time frame: Baseline and 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02042404, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.