- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02470494
The EarLens Contact Hearing Device (CHD) Spectrum Study (Spectrum)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92037
- California Hearing and Balance Center
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Menlo Park, California, United States, 94025
- Rodney Perkins Associates
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San Jose, California, United States, 95138
- Camino Ear Nose and Throat Clinic
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Louisiana
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Marrero, Louisiana, United States, 70072
- CNC Hearing and Balance Center
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North Carolina
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Raleigh, North Carolina, United States, 27609
- Carolina Ear and Hearing Clinic
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- Pittsburgh Ear Associates
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Texas
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San Antonio, Texas, United States, 78240
- Ear Medical Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
- 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)
- 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:
- 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;
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sound amplificatoin via EarLens CHD
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
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Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hearing Stability Using Unaided Air Conduction Thresholds.
Time Frame: Baseline and up to 90-day.
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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.
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Baseline and up to 90-day.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Speech Understanding in Noise.
Time Frame: Baseline and up to 90-day.
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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. |
Baseline and up to 90-day.
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Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.
Time Frame: Baseline and up to 90-day.
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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
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Baseline and up to 90-day.
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Change in Subject's Self-Perceived Ability to Communicate.
Time Frame: Baseline and up to 90-day.
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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.
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Baseline and up to 90-day.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Baseline and up to 90-day.
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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.
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Baseline and up to 90-day.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Brent Edwards, EarLens, Corp.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRP00009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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