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Completed

NCT Number: NCT02470494

The EarLens Contact Hearing Device (CHD) Spectrum 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.

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Hearing and Balance Center, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sound amplification provided via the EarLens CHD

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Speech Understanding in Noise.

    Time frame: 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.

  2. Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.

    Time frame: 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

  3. Change in Subject's Self-Perceived Ability to Communicate.

    Time frame: 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 outcomes

  1. Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

EarLens Corporation

Industry

Registry information

Acronym: Spectrum

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 12, 2015
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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