The EarLens Contact Hearing Device (CHD) Spectrum Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02470494

Acronym

Spectrum

Enrollment

Registered

2015-06-12

Start date

2015-06-30

Completion date

2016-11-30

Last updated

2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Sensorineural

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.

Interventions

DEVICESound amplification provided via the EarLens CHD

Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. Age 18 to 85 years. 2. Mild to severe hearing impairment between 125 to 8000 Hz. 3. Asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by MRI. 4. 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) 5. Greater than or equal to 50% on clinical speech discrimination demonstrating an ability to benefit from amplification; 6. 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 7. Experience with 1 or 2 air conduction hearing aids or previously evaluated for use with hearing aids; 8. Fluent speaker of American English due to use of American English study materials

Exclusion criteria

1. 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. 2. Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56

Design outcomes

Primary

Measure	Time frame	Description
Change in Hearing Stability Using Unaided Air Conduction Thresholds.	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.

Secondary

Measure	Time frame	Description
Change in Speech Understanding in Noise.	Baseline and up to 90-day.	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.	Baseline and up to 90-day.	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.	Baseline and up to 90-day.	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.

Other

Measure	Time frame	Description
Adverse Events	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	46
Total	46

Baseline characteristics

Characteristic	Sound Amplification Via EarLens CHD
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	34 Participants
Age, Categorical Between 18 and 65 years	12 Participants
Age, Continuous	68.5 years STANDARD_DEVIATION 10
Region of Enrollment United States	46 participants
Sex: Female, Male Female	9 Participants
Sex: Female, Male Male	37 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	34 / 46
serious Total, serious adverse events	0 / 46

Outcome results

Primary

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.