Trial Outcomes & Findings for The EarLens Contact Hearing Device (CHD) Spectrum Study (NCT NCT02470494)
NCT ID: NCT02470494
Last Updated: 2017-06-27
Results Overview
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.
COMPLETED
NA
46 participants
Baseline and up to 90-day.
2017-06-27
Participant Flow
Participant milestones
| Measure |
Sound Amplification Via EarLens CHD
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
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|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The EarLens Contact Hearing Device (CHD) Spectrum Study
Baseline characteristics by cohort
| Measure |
Sound Amplification Via EarLens CHD
n=46 Participants
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
|
|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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34 Participants
n=5 Participants
|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 90-day.Population: 40 subjects available for analysis between enrollment and 90-day measurement.
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.
Outcome measures
| Measure |
Sound Amplification Via EarLens CHD
n=40 Participants
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
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|---|---|
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Change in Hearing Stability Using Unaided Air Conduction Thresholds.
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-0.5 dB difference in Unaided Hearing
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline and up to 90-day.Population: 28 subjects available for analysis between enrollment/treatment and 90-day measurement.
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.
Outcome measures
| Measure |
Sound Amplification Via EarLens CHD
n=28 Participants
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
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|---|---|
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Change in Speech Understanding in Noise.
|
2.0 dB difference in HINT scores
Standard Deviation 3.8
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SECONDARY outcome
Timeframe: Baseline and up to 90-day.Population: 40 subjects available for analysis between enrollment/treatment and 90-day measurement.
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
Outcome measures
| Measure |
Sound Amplification Via EarLens CHD
n=40 Participants
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
|
|---|---|
|
Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.
|
27.2 dB difference in SF Hearing Thresholds
Standard Deviation 7.8
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SECONDARY outcome
Timeframe: Baseline and up to 90-day.Population: 40 subjects available for analysis between enrollment/treatment and 90-day measurement.
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.
Outcome measures
| Measure |
Sound Amplification Via EarLens CHD
n=40 Participants
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
|
|---|---|
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Change in Subject's Self-Perceived Ability to Communicate.
|
29.0 percentage of perceived benefit
Standard Deviation 17.1
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and up to 90-day.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.
Outcome measures
| Measure |
Sound Amplification Via EarLens CHD
n=46 Participants
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
|
|---|---|
|
Adverse Events
Inflammation/granulation tissue on TM
|
3 Participants
|
|
Adverse Events
External otitis
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1 Participants
|
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Adverse Events
Abrasion/blood/blister on tympanic membrane
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8 Participants
|
|
Adverse Events
Abrasion/blood/blister in ear canal
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34 Participants
|
|
Adverse Events
Ear discomfort/pain
|
7 Participants
|
|
Adverse Events
Ear tip, other: swelling, itching
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1 Participants
|
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Adverse Events
TM perforation
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1 Participants
|
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Adverse Events
Claustrophobia sensation
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1 Participants
|
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Adverse Events
Other: Petechia and Erythemia
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2 Participants
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Adverse Events
Sound Amplification Via EarLens CHD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sound Amplification Via EarLens CHD
n=46 participants at risk
Sound amplification provided via the EarLens CHD for subjects with hearing impairment.
Sound amplification provided via the EarLens CHD: Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
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|---|---|
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Ear and labyrinth disorders
Abrasion/blood/blister on tympanic membrane
|
15.2%
7/46 • 90-days
Subjects fitted with the Earlens Hearing Aid Device were evaluated for Adverse Events through 90-day follow-up.
|
|
Ear and labyrinth disorders
Abrasion/blood/blister in ear canal
|
54.3%
25/46 • 90-days
Subjects fitted with the Earlens Hearing Aid Device were evaluated for Adverse Events through 90-day follow-up.
|
|
Ear and labyrinth disorders
Ear discomfort/pain
|
10.9%
5/46 • 90-days
Subjects fitted with the Earlens Hearing Aid Device were evaluated for Adverse Events through 90-day follow-up.
|
|
Ear and labyrinth disorders
Ear tip, other: swelling, itching
|
2.2%
1/46 • 90-days
Subjects fitted with the Earlens Hearing Aid Device were evaluated for Adverse Events through 90-day follow-up.
|
|
Ear and labyrinth disorders
Inflammation/granulation tissue on TM
|
6.5%
3/46 • 90-days
Subjects fitted with the Earlens Hearing Aid Device were evaluated for Adverse Events through 90-day follow-up.
|
|
Ear and labyrinth disorders
External otitis
|
2.2%
1/46 • 90-days
Subjects fitted with the Earlens Hearing Aid Device were evaluated for Adverse Events through 90-day follow-up.
|
|
Ear and labyrinth disorders
TM perforation
|
2.2%
1/46 • 90-days
Subjects fitted with the Earlens Hearing Aid Device were evaluated for Adverse Events through 90-day follow-up.
|
|
Ear and labyrinth disorders
Claustrophobia sensation
|
2.2%
1/46 • 90-days
Subjects fitted with the Earlens Hearing Aid Device were evaluated for Adverse Events through 90-day follow-up.
|
|
Ear and labyrinth disorders
Other: Erythemia-pinpoint; or Petechia
|
4.3%
2/46 • 90-days
Subjects fitted with the Earlens Hearing Aid Device were evaluated for Adverse Events through 90-day follow-up.
|
Additional Information
Dr. Suzanne Levy, Director of Clinical Research
Earlens Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60