(45 days)
This product is used by hearing aid users as an accessory to remove Inis product is about by nearing overnight while they sleep.
A hearing aid drying appliance is an accessory for use by hearing aid users to remove moisture that collects in the hearing aid during normal use. Various products, most using a desiccant, have been in use for many years. Dry & Store uses a desiccant, a fan, and heat all common technologies - to remove much of the moisture. Along with drying, the product features a sanitizing cycle using a 4-watt ultraviolet bulb, commonly in use for a number of applications outside the hearing aid accessory market.
The provided document is a 510(k) summary for the "Dry & Store Hearing aid drying appliance." This document focuses on establishing substantial equivalence to existing devices and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) summary explicitly states:
"The manufacturer makes no claims as to degree of dryness, humidity level claimed after a drying cycle, or any other claim that suggests a minimum performance level."
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The document is primarily concerned with regulatory clearance based on substantial equivalence, not performance validation against specific metrics.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo and contact information for Ear Technology Corporation. The logo consists of the letters 'e', 't', and 'c', with the 't' having a horizontal bar above it. The contact information includes the address '207 E. Myrtle Ave., Johnson City, TN 37601' and two phone numbers: '(615) 928-9060' and '(615) 928-1424 (FAX)'.
Manufacturers of: the EarTech™ family of hearing products and EarFree™ Cerumen Removal Systems
510 (k) Summary
Submitter:
Ear Technology Corp. 207 E. Myrtle Avenue. Johnson City, TN 37601 Contact: Rick Gilbert (423) 928-9060 (423) 928-1424 fax
SEP - 8 1997
Prepared July 21, 1997
Trade Name: Dry & Store Hearing aid drying appliance Common Name: Classification Name: Accessory to Hearing Aid
A hearing aid drying appliance is an accessory for use by hearing aid users to remove moisture that collects in the hearing aid during normal use. Various products, most using a desiccant, have been in use for many years. Dry & Store uses a desiccant, a fan, and heat all common technologies - to remove much of the moisture. The manufacturer makes no claims as to degree of dryness, humidity level claimed after a drying cycle, or any other claim that suggests a minimum performance level.
Along with drying, the product features a sanitizing cycle using a 4-watt ultraviolet bulb, commonly in use for a number of applications outside the hearing aid accessory market. The manufacturer does not claim sterilization, nor do we claim that use of our product will completely eliminate problems associated with hearing aid use. On the other hand, a dry atmosphere and use of ultraviolet light to provide an unkind environment for bacterial growth is well known.
5
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a logo with the text "DEPARTMENT OF HEALTH &". The logo also contains a stylized image of what appears to be four human figures standing in a line. The figures are connected and have a wavy design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard J. Gilbert, Jr. Director of Marketing Ear Technology Corporation 207 E. Myrtle Avenue Johnson City, TN 37601
Re: K972776 Dry and Store (Air Conduction Hearing Aid Accessory (Dryer)) Dated: July 23, 1997 Received: July 25, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD
SEP - 8 1997
Dear Mr. Gilbert:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yifro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h. W. Liao Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
K972776/A'
510(k) Number (if known): K972776
Dry & Store Device Name:
Indications For Use:
This product is used by hearing aid users as an accessory to remove Inis product is about by nearing overnight while they sleep.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thind A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
SK-58
(Optional Format 1-2-96)
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.