Minneapolis Pad Printing for Hearing Aids
Lasting Impressions for Hearing Aid Logos
Hearing loss is attributable to a variety of causes, including genetics, infection, injury and aging. According to a recent study from the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS), “One in six U.S. adults ages 18 and older reports trouble hearing without a hearing aid.”
That means over 53 million U.S. adults could benefit from a hearing aid!
Hearing aid companies provide diverse hearing aid and implant devices that optimize comfort and understanding for people who experience mild to severe hearing loss.
With over 40 years of experience in the medical device printing industry, UniversalPromo offers quality, efficient printing services for Hearing Aid Companies. We became leaders in the industry because we never lost sight of our focus: You, our clients.
We approach your project like with approach every project, with a high level of attention to consistency and care. Our approach includes time-tested techniques to clarify your goals, establish a plan, and execute the plan with continual evaluation. Following this approach, UniversalPromo provides expert services to hearing aid companies from design, to engineering, to printing. We promise that your hearing aid and implant devices will be printed quickly and safely.
Pad Printing with Medical-Grade Inks on your hearing aids and devices
UniversalPromo prints hearing aid and implant devices using a technique called pad printing. Pad printing is a customizable printing process involving the transfer of a two-dimensional image to a three-dimensional surface. Our top-quality printing machines render high-resolution prints that translate to a variety of hearing aid and implant substrates. We print on substrates including but not limited to acrylic, soft vinyl, silicone, and polyethylene. UniversalPromo provides printing services for a variety of hearing aid and implant types such as:
Hearing Aid Pad Printing:
- In-the-ear (ITE)
- Behind-the-ear (BTE)
- In-the-canal (ITC)
- Completely-in-the-canal (CIC)
Implants Pad Printing:
- Cochlear implant (CI)
- Middle ear implant (MEI)
- Bone-anchored hearing aid (BAHA)
- Electro-acoustic stimulation implant (EAS)
- Auditory brainstem implant (ABI)
For printing on hearing aid and implant devices, UniversalPromo uses Class VI medical-grade inks. Our Class 6 medical-grade inks withstand various sterilization techniques including but not limited to chemical, heat and gas processes. Class 6 medical-grade inks are biocompatible, proving safe for regular contact with the human body. Our inks dry quickly, resulting in clear prints on hearing aid and implant devices for infants, children, and adults. We can adjust inks by color and opacity to ensure your branding appears consistent across a wide range of designs.
FDA Compliance Regulations for Hearing Aids
The Food and Drug Administration (FDA) provides regulations that require compliance from Hearing Aid Companies. According to the FDA’s Code of Federal Regulations (CFR), hearing aids must be labeled with the following information:
- Name of manufacturer or distributor
- Model name or number
- Serial number
- Manufacture year
UniversalPromo is proud to be an industry leader in medical device printing. We know compliance! In addition to our medical-grade inks and knowledge of FDA regulations, UniversalPromo’s equipment and printing techniques meet the industry’s most stringent standards for safety and compliance.
Can you hear this? Pre-Market Approval
Hearing Aid Companies seeking pre-market approval (PMA) from the FDA for hearing aids or implants requires additional considerations prior to approval and production for market. The FDA classifies hearing aids and implants as medical devices. Depending on the style, the FDA classifies hearing aids and implants as Class I, Class II, or Class III medical devices. The FDA classification of your hearing aid or implant device determines whether or not your product will be subject to FDA regulations prior to approval.
Please note following regarding pre-market approval:
- Class I hearing aid devices do not require premarket approval. Class I devices may include air-conduction hearing aids.
- Class II devices may or may not require premarket approval. Class II devices may include bone-conduction, wireless and transcutaneous air-conduction hearing aid systems.
- Class III devices require premarket approval. Class III devices may include cochlear implants.
At UniversalPromo, we regularly provide pad printing services to clients with Class I, Class II, and Class III medical devices. If your hearing aid or implant requires premarket approval, we can work with you from early in the design and prototyping process to ensure your product design meets all FDA compliance standards.
Click here for more information on our services for Medical Device Designers.
Squeaky Clean Environment and Documentation
Hearing Aid Companies can rely upon UniversalPromo to complete projects utilizing safe practices and equipment. We complete every printing project in a clean environment. We subject our clean rooms to regular, comprehensive cleaning, as well as careful regulation of equipment and personnel processes, air flow and other environmental conditions. At UniversalPromo, we pledge to protect your hearing aid and implant devices from contamination during the printing process. We will uphold all compliance standards to highest degree in order to ensure the integrity of your product, as well as safe use for hearing aid and implant customers.
In order to demonstrate that your hearing aid and implant devices have been printed compliantly, UniversalPromo provides clients with documentation that outlines the printing process. Our documentation details all information relative to FDA standards for printing on medical devices. We also document each project in order to make adjustments as needed and ensure repeatability. Clients may request data sheets from UnivesralPromo that further document material safety, as well as certificates of compliance for our inks.
Listen to the experts
At UniversalPromo, we appreciate a good challenge! We know that Hearing Aid Companies require printing on a variety of devices, including those so small that they are marketed as “invisible!” For every hearing aid design, shape and size, we’re here for you. Our expert graphic design team use the latest design programs to develop branding conventions for consistent and clear translation onto every device. Our in-house engineering department utilizes top-quality equipment to design and build printing processes that work for even the most challenging projects. Whether you come to us with a one-time order or a large-scale, continuing project, UniversalPromo will offer our very best to you. You can expect exceptional service and results, every time. We guarantee it.
Have any questions for us? Connect with us here. We look forward to speaking with you!