Hearing Loss, SensorineuralSpectrumNCT02470494
The EarLens Contact Hearing Device (CHD) Spectrum Study
A study testing Sound amplification provided via the EarLens CHD in people with Hearing Loss, Sensorineural, run by EarLens Corporation at 8 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 the proposed study (Extended Investigation under the Continued Access Policy) is to continue to allow access to the investigational medical… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Sound amplification provided via the EarLens CHD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2015to Nov 2016
- 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 8000 Hz.
- Asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by MRI.
- No significant conductive hearing impairment;
- No more than a 10 dB air-bone gap at 3 of 4 tested frequencies (500, 1000, 2000, or 4000 Hz)
- Normal Type A tympanometry (indicating normal mobility of the tympanic membrane and middle ear bones)
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- 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
Who cannot join
- The Subject must not have known or active medical issues that would preclude having a hearing device, including:
- an abnormal TM (deemed perforated, inflamed or has a dimeric or monomeric area, or in any other way abnormal);
- an abnormal middle ear or a history of prior middle ear surgery other than tympanostomy tubes;
- an ear canal anatomy that prevents the physician from seeing an adequate amount of the tympanic membrane.
- an anatomical configuration of the external auditory canal that prevents satisfactory placement of the TMT
- a history of chronic and recurrent ear infections in the past 24 months;
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- a rapidly progressive or fluctuating hearing impairment;
- diagnosed with having a compromised immune system which may impact the tissue of the auricle or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or received radiation of the head ever or chemotherapy for cancer within the last six years.
- Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Iowa
Iowa City, Iowa, 52242
California Hearing and Balance Center
La Jolla, California, 92037
CNC Hearing and Balance Center
Marrero, Louisiana, 70072
Rodney Perkins Associates
Menlo Park, California, 94025
Pittsburgh Ear Associates
Pittsburgh, Pennsylvania, 15212
Carolina Ear and Hearing Clinic
Raleigh, North Carolina, 27609
Ear Medical Group
San Antonio, Texas, 78240
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 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.
Read the detailed description
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.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Sound amplification provided via the EarLens CHD
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound amplification provided via the EarLens CHDDevice
Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
| Study group | Role | What they receive |
|---|---|---|
| Sound amplificatoin via EarLens CHD | Experimental | Sound amplification provided via the EarLens CHD for subjects with hearing impairment. Receives: Device: Sound amplification provided via the EarLens CHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 90-day.
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Baseline and up to 90-day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionNov 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- EarLens Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brent Edwards, Study director, EarLens, Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470494
- Sponsor's protocol ID
- CRP00009
- Acronym
- Spectrum
- Status last verified
- May 2017
- First submitted
- 8 Jun 2015
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30300158
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EarLens Contact Hearing Device (CHD) Spectrum Study
- ClinicalTrials.gov ID
- NCT02470494
- Acronym / sponsor ID
- Spectrum / CRP00009
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- EarLens CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Posted 27 Jun 2017
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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sound amplificatoin via EarLens CHD | Experimental | Device: Sound amplification provided via the EarLens CHDSound amplification provided via the EarLens CHD for subjects with hearing impairment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (9 listed)
- 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
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 the EarLens CHDSubjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD. | Device | Sound amplificatoin via EarLens CHD |
Primary outcome
Change in Hearing Stability Using Unaided Air Conduction Thresholds.
Time frame: Baseline and up to 90-day.
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.
3 secondary outcomes
Change in Speech Understanding in Noise.
Time frame: Baseline and up to 90-day.
Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.
Time frame: Baseline and up to 90-day.
Change in Subject's Self-Perceived Ability to Communicate.
Time frame: Baseline and up to 90-day.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: No
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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.
Brent Edwards study director
EarLens, Corp.
8 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 the EarLens CHD in people with Hearing Loss, Sensorineural, run by EarLens Corporation at 8 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 10 inclusion and 9 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 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 27 Jun 2017). 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 Hearing Stability Using Unaided Air Conduction Thresholds. (time frame: Baseline and up to 90-day.). 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 NCT02470494, which also lists 1 linked publication.
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 27 Jun 2017; AzTrials last refreshed its copy on 29 Oct 2026.