Wireless Earlens Light Driven Hearing Aid

K153634 · Earlens Corporation · PLK · Apr 6, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K153634
• Device Name: Wireless Earlens Light Driven Hearing Aid
• Applicant: Earlens Corporation
• Product Code: PLK · Ear, Nose, Throat
• Decision Date: Apr 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3315
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The wireless Earlens Light Driven Hearing Aid (a.k.a. Earlens Hearing Aid) transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.

Device Story

Wireless Earlens Light Driven Hearing Aid transmits amplified sound via direct eardrum vibration. System consists of behind-the-ear processor and tympanic membrane contact transducer. Processor captures acoustic signals, converts to light pulses; light pulses transmitted to transducer on eardrum; transducer converts light to mechanical vibration, stimulating hearing. Used by adults with sensorineural hearing loss; prescribed and fitted by hearing healthcare professionals. Provides amplification across 125 Hz - 10,000 Hz spectrum. Benefits patients by providing direct mechanical stimulation to eardrum, potentially improving sound clarity and frequency response compared to traditional air-conduction hearing aids.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) review process.

Technological Characteristics

Tympanic membrane contact hearing aid; light-driven transduction mechanism; frequency range 125 Hz - 10,000 Hz; consists of external sound processor and internal tympanic membrane contact transducer.

Indications for Use

Indicated for individuals 18 years and older with mild to severe sensorineural hearing impairment who can benefit from amplification.

Regulatory Classification

Identification

A tympanic membrane contact hearing aid is a prescription wearable device that compensates for impaired hearing. Amplified sound is transmitted by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane. A tympanic membrane contact hearing aid is subject to the requirements in § 801.422 of this chapter.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The patient contacting components must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and must include: (i) Mechanical integrity testing; (ii) Electrical and thermal safety testing; (iii) Software verification, validation, and hazard analysis; (iv) Reliability testing consistent with expected device life; (v) Electromagnetic compatibility testing; and (vi) Validation testing of device output and mechanical force applied to the tympanic membrane in a clinically appropriate model. (3) Clinical performance testing must characterize any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. (4) Professional training must include the ear impression procedure, correct placement, fitting, monitoring, care, and maintenance of the device. (5) Labeling must include the following: (i) A detailed summary of the adverse events and effectiveness outcomes from the clinical performance testing; (ii) Detailed instructions on how to fit the device to the patient; (iii) Instructions for periodic cleaning of any reusable components; (iv) Information related to electromagnetic compatibility; and (v) Patient labeling that includes: (A) A patient card that identifies if a patient has been fitted with any non-self- removable components of the device and provides relevant information in cases of emergency; (B) Information on how to correctly use and maintain the device; (C) The potential risks and benefits associated with the use of the device; and (D) Alternative treatments.

In combination with the general controls of the FD&C Act, the tympanic membrane contact hearing aid is subject to the following special controls:

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 6, 2016

Earlens Corporation Ms. Deborah Arthur Regulatory Consultant 4045-A Campbell Avenue Menlo Park, CA 94025

Re: K153634

Trade/Device Name: Wireless Earlens Light Driven Hearing Aid Regulation Number: 21 CFR 874.3315 Regulation Name: Tympanic Membrane Contact Hearing Aid Regulatory Class: Class II Product Code: PLK Dated: January 6, 2016 Received: January 7, 2016

Dear Ms. Arthur:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name

wireless EarLens Light Driven Hearing Aid

#### Indications for Use (Describe)

The wireless Earlens Light Driven Hearing Aid (a.k.a. Earlens Hearing Aid) transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. The device can provide the full spectrum of amplification that includes 125 Hz - 10,000 Hz.

Type of Use (Select one or both, as applicable)

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
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