FDA & State Regulatory Information

FDA Disclaimer

Club Hearing Intl supplies hearing aid devices and related equipment exclusively to licensed hearing care professionals, including audiologists, hearing instrument specialists, otolaryngologists (ENTs), and authorized medical distributors.

Products offered on this website include prescription medical devices that are regulated by the U.S. Food and Drug Administration (FDA) and are intended solely for professional use in clinical or authorized settings.

We do not sell or ship hearing aids directly to consumers or patients. Any attempt to purchase prescription hearing aids without appropriate credentials may result in order cancellation and potential reporting to regulatory authorities.

Nothing on this website should be interpreted as medical advice or a substitute for professional consultation, diagnosis, or treatment by a licensed provider.

All users and purchasers must affirm that they are legally authorized to dispense hearing aid devices in accordance with federal, state, and local regulations.

Club Hearing and Club Hearing Intl disclaim all liability for misuse, unauthorized distribution, or consumer directed use of prescription devices purchased through this platform.

The site may require submission of a hearing test or confirmation of care by a licensed provider. We reserve the right to refuse sales that do not comply with federal or state law. Devices are dispensed in accordance with FDA and state licensure rules.

Notice Regarding Medical Opinion

If you are a resident of Alabama, Colorado, District of Columbia, Florida, Hawaii, Iowa, Kentucky, Massachusetts, Nebraska, New Hampshire, New Mexico, New York, New Jersey, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Texas, or Wyoming, you must read and acknowledge the applicable statement from your state below.

Alabama

The purchaser has been advised at the outset of his or her relationship with the hearing instrument apprentice, fitter, or dispenser that any examination(s) or representation(s) made by a licensed hearing instrument apprentice, fitter, or dispenser in connection with the fitting and selling of this hearing instrument(s) is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and, therefore, must not be regarded as medical opinion or advice.

Colorado

The buyer has been advised at the outset of the buyer's relationship with the dispenser that any examination or representation made by a dispenser in connection with the practice of dispensing, fitting, or dealing in hearing aids is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and, therefore, must not be regarded as medical opinion or advice.

District of Columbia

This hearing aid will not restore normal hearing nor will it prevent further hearing loss. A return visit to a physician who is an ear specialist or audiologist after the purchase of this aid will help you in best adapting to it.

Florida

A hearing aid will not restore normal hearing, nor will it prevent further hearing loss.

Hawaii

The purchaser has been advised at the outset of the purchaser's relationship with the hearing aid dealer and fitter that any examination or representation made by a hearing aid dealer and fitter in connection with the fitting and selling of this hearing aid is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this State and shall not be considered as medical opinion or advice.

Iowa

The purchaser has been advised that any examination or representation made by a licensed hearing aid specialist in connection with the fitting or selection and selling of this hearing aid is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and therefore, must not be regarded as medical opinion or advice.

Kentucky

The purchaser has been advised at the outset of his or her relationship with the specialist in hearing instruments that any examination(s) or representation(s) is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and therefore shall not be regarded as medical opinion or advice.

Massachusetts

This hearing aid will not restore normal hearing nor will it prevent further hearing loss. The sale of a hearing aid is restricted to those individuals who have obtained a medical evaluation from a licensed physician or otolaryngologist. A fully informed adult whose religious or personal beliefs preclude consultation with a physician may waive the requirement of a medical evaluation. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged. It is also required that a person under the age of eighteen years obtain an evaluation by an audiologist in addition to the medical evaluation before a hearing aid can be sold to such person.

Nebraska

The purchaser has been advised at the outset of his or her relationship with the hearing instrument specialist that any examination or representation made by a licensed hearing instrument specialist in connection with the fitting and selling of this hearing instrument is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and therefore must not be regarded as medical opinion or advice.

New Hampshire

This hearing aid will not restore normal hearing nor will it prevent further hearing loss.

New Mexico

Buyer has been advised that licensee is not a licensed physician and that the examination and recommendation is made as a hearing aid dispenser or audiologist and not as a medical diagnosis or prescription.

New York

The buyer has been advised at the outset of his or her relationship with a Club Hearing audiologist that any examination or representation made by a hearing aid dispenser in connection with the business of dispensing this hearing aid, or hearing aids, is not an examination, diagnosis, or prescription by a person licensed to practice medicine in New York, and therefore, must not be regarded as medical opinion.

New Jersey

The purchaser has been advised at the outset of his or her relationship with the hearing aid dispenser that any examination or representation made by a licensed hearing aid dispenser in connection with the practice of fitting and selling of this hearing aid, or hearing aids, is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this State, or by certified audiologists and therefore must not be regarded as medical opinion.

North Dakota

Any examination or representation made by a licensed hearing aid specialist in connection with the fitting and selling of this hearing instrument is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and therefore, must not be regarded as medical opinion or advice.

Ohio

The purchaser is advised that any examination, fitting, recommendation, or representation made by a licensed hearing aid dealer or fitter in connection with the sale of this hearing aid is not an examination, diagnosis, or prescription made by a person licensed to practice medicine in this state and therefore must not be regarded as medical opinion or advice.

Oklahoma

Any examination or representation made by a licensed hearing aid dealer and fitter in connection with the fitting and selling of this hearing aid is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and therefore must not be regarded as medical opinion or advice. Further, it is recommended that medical advice from a licensed physician should be obtained.

Oregon

It is desirable that a person seeking help with a hearing problem (especially for the first time) consult an ear doctor and obtain a clinical hearing evaluation. Although hearing aids are often recommended for hearing problems, another form of treatment may be necessary.

Pennsylvania

The purchaser has been advised at the outset of his or her relationship with the hearing aid dealer that any examination or representation made by a registered hearing aid dealer and fitter in connection with the practice of fitting and selling of this hearing aid is not an examination, diagnosis or prescription by a person licensed to practice medicine in this Commonwealth and therefore must not be regarded as medical opinion.

Rhode Island

The purchaser has been advised at the outset of his/her relationship with the hearing aid dealer that any examination(s) or representation(s) made by a licensed hearing aid dealer and fitter in connection with the fitting and selling of this hearing aid(s) is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and therefore must not be regarded as medical opinion or advice.

Texas

The client has been advised that any examination or representation made by a licensed hearing instrument dispenser or apprentice permit holder or temporary training permit holder in connection with the fitting and selling of the hearing instrument(s) is not an examination, diagnosis or prescription by a person duly licensed and qualified as a physician or surgeon authorized to practice medicine in the State of Texas and, therefore, must not be regarded as medical opinion or advice.

Wyoming

The purchaser has been advised that any examination or representations made by a licensed hearing aid specialist in connection with either the fitting or selling of this hearing aid is not an examination, diagnosis or prescription by a person licensed to practice medicine in this state and shall not be regarded as medical opinion.

Notice of State Boards and Regulators

The following information is provided to comply with applicable state laws regarding hearing aid sales, licensing, and consumer complaints.

Alaska

Buyer may file a written complaint about a hearing aid or a hearing aid dealer with:

Alaska Department of Commerce, Community, and Economic Development P.O. Box 110800
Juneau, AK 99811-0800
Colorado

Dispensers who are licensed, certified, or registered by the Department of Regulatory Agencies are regulated by the Division of Professions and Occupations. Complaints may be filed by contacting:

Colorado Office of Audiology and Hearing Aid Provider Licensure Division of Professions and Occupations
1560 Broadway, Suite 1350
Denver, CO 80202
Phone: (303) 894-7800
Website: colorado.gov/pacific/dora/Hearing_Aid_Provider
District of Columbia

Complaints with respect to this purchase may be submitted to:

Office of the Attorney General, Office of Consumer Protection 441 4th Street, NW
Washington, DC 20001
Florida

Any complaint concerning the hearing aid and guarantee therefor, if not reconciled with the licensee from whom the hearing aid was purchased, should be directed to:

Florida Department of Health, Consumer Services Unit Bald Cypress Way, Bin C-75
Tallahassee, FL 32399-3260
Phone: (850) 488-0796
Idaho

If you have general questions or questions regarding procedures for filing complaints against anyone licensed to dispense hearing aids, you may contact:

Idaho Bureau of Occupational Licenses P.O. Box 83720
Boise, ID 83720-0063
Phone: (208) 334-3233
Website: ibol.idaho.gov
Kentucky

Any complaints concerning the sale or service of this hearing instrument which are not corrected by the specialist in hearing instruments should be directed to:

Kentucky Licensing Board for Specialists in Hearing Instruments Commonwealth of Kentucky
Frankfort, KY 40601
Louisiana
Louisiana State Board of Hearing Aid Dealers 308 Gregory Drive
Luling, LA 70070
Phone: (504) 655-0383
Maine

If you wish to file a complaint regarding this purchase, contact:

Complaint Coordinator, Office of Professional and Occupational Regulation 35 State House Station
Augusta, ME 04333
Phone: (207) 624-8660
Website: maine.gov/professionallicensing
Montana

If you have any questions regarding your consumer rights with respect to hearing aids and related devices, contact:

Montana Board of Hearing Aid Dispensers 301 South Park, 4th Floor
P.O. Box 200513
Helena, MT 59620-0513
Phone: (406) 841-2202
New Hampshire

Complaints which arise with respect to this transaction may be submitted in writing to:

New Hampshire Consumer Protection and Antitrust Bureau Division of Public Protection
New Hampshire Department of Justice
33 Capitol Street
Concord, NH 03301
Phone: (603) 271-3658
New Mexico
Speech Language Pathology, Audiology and Hearing Aid Dispensing Practices Board P.O. Box 25101
Santa Fe, NM 87504
Phone: (505) 476-4622
Oklahoma

If the hearing aid provider fails to comply with state requirements for returns, complaints should be forwarded to:

Oklahoma State Department of Health, Occupational Licensing Division 1000 N.E. 10th Street
Oklahoma City, OK 73117
Oregon

Complaints regarding the purchase of hearing aids may be made to:

Oregon Health Licensing Agency 1430 Tandem Avenue NE, Suite 180
Salem, OR 97301
Phone: (503) 373-2024
Website: oregon.gov/OHA/PH/HLO
Pennsylvania

If your rights are violated, you may contact:

  • Pennsylvania State Bureau of Consumer Protection
  • Pennsylvania Department of Health in Harrisburg
  • Your local District Attorney
Tennessee

A buyer may contact the following council regarding complaints on any matter relating to the fitting and dispensing of hearing instruments:

Tennessee Council for Hearing Instruments Specialists 665 Mainstream Drive, 2nd Floor
Nashville, TN 37243
Phone: (615) 741-5735
Toll Free: 1-800-778-4123
Texas

If you have a complaint against a licensed hearing instrument dispenser, apprentice permit holder, or temporary training permit holder, you may contact:

Texas Department of Licensing and Regulation P.O. Box 12157
Austin, TX 78711
Phone: (512) 463-6599
Toll Free (Texas): (800) 803-9202
Website: tdlr.texas.gov