Back to resultsThe EarLens Contact Hearing Device (CHD) Spectrum Study (Spectrum)
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sound amplification provided via the EarLens CHD
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural
Eligibility Criteria
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
Sites / Locations
- California Hearing and Balance Center
- Rodney Perkins Associates
- Camino Ear Nose and Throat Clinic
- University of Iowa
- CNC Hearing and Balance Center
- Carolina Ear and Hearing Clinic
- Pittsburgh Ear Associates
- Ear Medical Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sound amplificatoin via EarLens CHD
Arm Description
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02470494
Brief Title
The EarLens Contact Hearing Device (CHD) Spectrum Study
Acronym
Spectrum
Official Title
The EarLens Contact Hearing Device (CHD) Spectrum Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EarLens Corporation
4. Oversight
Data Monitoring Committee
No
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sound amplificatoin via EarLens CHD
Arm Type
Experimental
Arm Description
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Intervention Type
Device
Intervention Name(s)
Sound amplification provided via the EarLens CHD
Intervention Description
Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
Primary Outcome Measure Information:
Title
Change in Hearing Stability Using Unaided Air Conduction Thresholds.
Description
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.
Time Frame
Baseline and up to 90-day.
Secondary Outcome Measure Information:
Title
Change in Speech Understanding in Noise.
Description
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.
Time Frame
Baseline and up to 90-day.
Title
Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.
Description
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
Time Frame
Baseline and up to 90-day.
Title
Change in Subject's Self-Perceived Ability to Communicate.
Description
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.
Time Frame
Baseline and up to 90-day.
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
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.
Time Frame
Baseline and up to 90-day.
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent Edwards
Organizational Affiliation
EarLens, Corp.
Official's Role
Study Director
Facility Information:
Facility Name
California Hearing and Balance Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Rodney Perkins Associates
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
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
CNC Hearing and Balance Center
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Carolina Ear and Hearing Clinic
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Pittsburgh Ear Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Ear Medical Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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
Learn more about this trial
The EarLens Contact Hearing Device (CHD) Spectrum Study
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