(41 days)
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies).
Magna-PWR, Magna-B, Integra 70-74, Futura 67M-68M, MP97, Supra 51-52, Supra 56-59 and Suprema 45-48 Hearing Aids
I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is a 510(k) premarket notification approval letter for various hearing aid models from 1997. It confirms substantial equivalence to previously marketed devices and outlines general regulatory compliance and concerns about electromagnetic interference.
Specifically, the text does not include:
- Acceptance criteria tables for device performance.
- Details of any specific studies (e.g., sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies).
- Information on how ground truth was established for any training or test sets.
The included "Indications For Use" pages describe the types and severity of hearing loss these hearing aids are intended to address, but this is not a performance study or a set of acceptance criteria.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 1997
Don Campbell President Perfect® Ear Incorporated PO Box 526050 Longwood, FL 32752
Re:
K973861 Magna-PWR and Magna-B Hearing Aids Dated: October 7, 1997 Received: October 9, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Campbell:
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 the Electronic Product 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.
While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporarily ineffective for the wearer. Because electromagnetic interference may affect your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of clectromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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,
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
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1997
Don Campbell Vice President, Operations Magnatone Hearing Aid Corporation P.O. Box 180964 Casselberry, Florida 32718-0964
Re: K973861 Hearing Aid Models: Magna-PWR, Magna-B, Integra 70-74, Futura 67M-68M, MP97, Supra 51-52, Supra 56-59 and Suprema 45-48 Dated: October 7, 1997 Received: October 9, 1997 Regulatory Class: T 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Campbell:
.. .
This letter corrects our substantially equivalent letter of November 4, 1997, regarding the company name and address being incorrect, and not all model names being included in the trade name.
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 The general controls provisions of the Act include provisions of the Act. 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Reqister. 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page - 2 - Mr. Don Campbell
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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note that the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
:
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Page 1 of 1_
510(k) Number (if known): _
Device Name: ____________________________
Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids The indication for use or can airy sound for individuals
in this submission is to amplify sound for indicated for in this submission is co ampiss been are indicated for with imparred hearing. The devices and
| Severity: |
|---|
| 1. Slight |
| 2. Mild |
| X 3. Moderate |
| X 4. Severe |
| X 5. Profound |
| Configuration: |
|---|
| 1. High Frequency- Precipitously Sloping |
| X 2. Gradually Sloping |
| X 3. Reverse Slope |
| X 4. Flat |
| 5. Other |
| Other |
|---|
| 1. Low Tolerance To Loudness |
| 2. |
B. Specific Indications (Only if appropriate.) : ecitic indications (olis) in appear as improved speech (Most psychoacousers indreacrons Castlers of the supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted device (per 21 CFR 801.420 &21 CFR 801.42
CFR 801.421)
William
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
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Page 1 of_1
510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________ Integra 70, 71, 72, 73, 74-Device Name: _ Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids
to and consisted in to amplify sound for individuals The indication for use of the aff conund for individuals
in this submission is to amplify sound for indicated for in this submission is to amplify sound some indicated for with impaired hearing. The devices are
individuals with losses in the following category(ies).
| Severity: | Configuration: | Other |
|---|---|---|
| X 1. Slight | X 1. High Frequency - Precipitously Sloping | X 1. Low Tolerance To Loudness (73 & 74 Only) |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | |
| X 4. Severe | X 4. Flat | |
| 5. Profound | 5. Other |
B. Specific Indications (Only if appropriate.) : ecific Indications (Ohly It appropriase improved speech
(Most psychoacoustic indications such as improved by (Most psychoacoustic Indicacions Sach as any intelligibility in background noise, must be supported by clinical data.)
- 1 .
-
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
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Page 1 of 1 -
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Futura. 68M Futura 67M, Device Name: Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids
to the country in anim to amplify sound for individuals The indication for use on che dif essund for individuals
in this submission is to The dovices are indicated for in this submission is to amplify bound care indicated for
with impaired hearing. In the following category(ies) with imparred hearing. The devices are are are are are aregory(ies).
| Severity: | Configuration: | Other |
|---|---|---|
| 1. Slight | X 1. High Frequency- Precipitously Sloping | 1. Low ToleranceTo Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | |
| X 4. Severe | X 4. Flat | |
| X 5. Profound | 5. Other |
B. Specific Indications (Only if appropriate.) : ecitic Indications (oily re appears as improved speech
(Most psychoacoustic indications such as improrted by (Most psychoacoustic Indications our must be supported by clinical data.)
- 1 .
-
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Restricted device (per 21 CFR 801.420 &21/CFR\801.421) | |||||
|---|---|---|---|---|---|
| (Division Sign-Off)Children and | Company of the country of the country of the transmission of the transmission of the comments of the comments of the comments of the comments of the comments of the comments |
Division of Reproductive, Abdominal, ENT, and Radiological I 510(k) Number
{7}------------------------------------------------
Page 1 of 1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals In this submission is of the devices are indicated for with imparred hearing. Inc estegory(ies).
| Severity: | |
|---|---|
| 1. Slight | |
| 2. Mild | |
| 3. Moderate | |
| X 4. Severe | |
| X 5. Profound | |
| Configuration: | |
| X 1. High Frequency- Precipitously Sloping | |
| X 2. Gradually Sloping | |
| X 3. Reverse Slope | |
| X 4. Flat | |
| 5. Other | |
| Other | |
| X 1. Low ToleranceTo Loudness | |
| 2. |
B. Specific Indications (Only if appropriate.) : (Most psychoacoustic (only) as improved speech (MOSC pSychoacoubers akground noise, must be supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Restricted device (per 21 CFR 801.420 &21 CFR-801/.421, | |||
|---|---|---|---|
| (Division Sign-Off) | |||
| The first of the country of the country of the country of the county of the county of |
Division of Reproductive, Abdominal, ENT. and Radiological Devic 510(k) Number
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Page_1___of_1___
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Supra 51 & 52 Device Name: _
Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids
to the succession is to amplify sound for individuals The indication is to amplify sound for individuals
in this submission is to amplify sound for indicated for in this submission is co amplity bounder are indicated for with imparred hearing. The device of the following category(ies).
individuals with losses in the following category(ies).
| Severity: | Configuration: | Other | |||
|---|---|---|---|---|---|
| 1. Slight | X 1. High Frequency - Precipitously Sloping | X 1. Low Tolerance To Loudness (51 only) | |||
| X 2. Mild (51) | X 2. Gradually Sloping | 2. | |||
| X 3. Moderate | X 3. Reverse Slope | ||||
| X 4. Severe(51-52) | X 4. Flat | ||||
| 5. Profound | 5. Other |
B. Specific Indications (Only if appropriate.) : ecitic Thatcacions (only re approved speech as improved speech (Most psychoacoustic indreadions one must be supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted device (per 21 CFR 801.420 &21/CFR 801 . 4
서비스 (100) 2017
the first of the first of the first of
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic
510(k) Number K973801
{9}------------------------------------------------
Page 1 of 1
510(k) Number (if known) :____
Supra 56, 57, 58, 59. Device Name:
Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals In this Submibiler in The devices are indicated for with imparred hearing.
| Severity: | Configuration: | Other |
|---|---|---|
| 1. Slight | X 1. High Frequency- Precipitously Sloping | X 1. Low Tolerance (57, 58,To Loudness |
| 2. Mild | X 2. Gradually Sloping | X 2. Directional (56) |
| X 3. Moderate | X 3. Reverse Slope | |
| X 4. Severe | X 4. Flat | |
| X 5. Profound | 5. Other |
Specific Indications (Only if appropriate.) : B. (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Restricted device (per 21 CFR 801.420 &21 CFR, 801.421) | |
|---|---|
| illaus ma |
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
{10}------------------------------------------------
Page 1 of _l
510 (k) Number (if known) : __ Suprema 45 & 46 Device Name: Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals in chis submited hearing. The devices are indicated for with imparred hearing.
individuals with losses in the following category(ies).
| Severity: | |
|---|---|
| 1. Slight | |
| X 2. Mild | |
| X 3. Moderate | |
| 4. Severe | |
| 5. Profound | |
| Configuration: | |
| 1. High Frequency | |
| - Precipitously Sloping | |
| X 2. Gradually Sloping | |
| X 3. Reverse Slope | |
| X 4. Flat | |
| 5. Other | |
| Other | |
| X 1. Low Tolerance To Loudness | |
| 2. |
B. Specific Indications (Only if appropriate.) : (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
- 1 .
-
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted device (per 21 CFR 801.420 &21
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973861
{11}------------------------------------------------
Page 1 of 1
510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________
Suprema 47 Device Name:
Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies).
| Severity: | Configuration: | Other |
|---|---|---|
| 1. Slight | X 1. High Frequency- Precipitously Sloping | X 1. Low ToleranceTo Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | |
| X 4. Severe | X 4. Flat | |
| 5. Profound | 5. Other |
B. Specific Indications (Only if appropriate.) : (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Restricted device (per 21 CFR 801.420/&21 CFR 801.421) | ||||||
|---|---|---|---|---|---|---|
| 10 01 000 |
(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological De 510(k) Number
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Page 1 of_________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): _
Device Name: ____Suprema 48
Indications For Use:
- A. General Indications:
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals In this submission is of the devices are indicated for with imparred hearing.
individuals with losses in the following category(ies).
| Severity: | |
|---|---|
| 1. Slight | |
| 2. Mild | |
| X 3. Moderate | |
| X 4. Severe | |
| 5. Profound | |
| Configuration: | |
| 1. High Frequency- Precipitously Sloping | |
| X 2. Gradually Sloping | |
| X 3. Reverse Slope | |
| X 4. Flat | |
| 5. Other | |
| Other | |
| X 1. Low Tolerance To Loudness | |
| 2. |
B. Specific Indications (Only if appropriate.) : (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
-
- 2 .
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Restricted device (per 21 CFR 801.420 &21 OFR 80D.471) | |
|---|---|
| -------------------------------------------------------- | -- |
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
§ 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.