healthcare laws and regulations may involve substantial costs. It is possible that governmental authorities may conclude that our business practices, including, without limitation, our revenue sharing arrangements with our partners, our arrangements with the hearing aid manufacturers, our arrangements with providers licensed to practice audiology or to dispense hearing aids, our arrangements with entities that provide us with rebate administrative services, and our sales and marketing practices, do not comply with applicable fraud and abuse or other healthcare laws and regulations or guidance.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from government-funded healthcare programs, such as Medicare and Medicaid, and additional oversight, monitoring and reporting requirements if we become subject to a corporate integrity agreement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of our operations. If any of the medical device manufacturers (including hearing aid manufacturers), marketing partners or other entities with whom we do business is found not to be in compliance with applicable laws, they may be subject to the same criminal, civil or administrative sanctions, including exclusion from government-funded healthcare programs.
The products that we sell are subject to extensive government regulation and oversight by the FDA. We rely on our third-party suppliers to comply with applicable requirements, and their failure to do so, may materially and adversely affect our business.
In the United States, the design, development, research, manufacture, testing, labeling, promotion, advertising, distribution, marketing, sale and export and import of hearing instruments are subject to regulation by numerous governmental authorities, including by the FDA as medical devices. Specifically, the Federal Food, Drug, and Cosmetic Act, or the FDCA, as well as FDA regulations and other federal and state statutes and regulations, govern, among other things, medical device design and development, preclinical and clinical testing, device safety, premarket clearance or approval, establishment registration and device listing, manufacturing, labeling, storage, record-keeping, advertising and promotion, sales and distribution, export and import, recalls and field safety corrective actions and post-market surveillance, including complaint handling and medical device reporting of adverse events.
We rely on our third-party suppliers to comply with applicable requirements relating to the products that they manufacture and supply to us for sale to our customers. If these third parties fail to comply with applicable requirements, our operations could be disrupted and we may be required to contract with alternate suppliers, which could result in substantial delays and which could materially and adversely affect our business, financial conditions, results of operations and growth prospects.
Risks Related to the Corporate Reorganization and Our Operation as a Stand-alone Business
The hear.com group is subject to a number of risks in connection with the Corporate Reorganization, the transitional services agreement and its operation as a stand-alone business.
Prior to the consummation of this offering, the hear.com group has been part of the WS Audiology Group and will only be separated into a stand-alone business in connection with this offering. See “Corporate Reorganization.” Certain business functions are currently and will, pursuant to a transitional services agreement (the “TSA”), continue to be carried out centrally by the WS Audiology Group for a limited period of time following the Corporate Reorganization, including certain IT applications, payroll services, arrangements with logistics providers and legal services. We expect that the TSA will initially be for a term of nine months, with the option for us to extend the term for one period of three months, subject to early termination rights based on advance written notice. The TSA, and the Corporate Reorganization more generally, will be negotiated prior to this offering, at a time when the hear.com group will still be part of the WS Audiology Group. The agreements generally will be entered into on arms-length terms similar to those that would be agreed with an unaffiliated third party such as a buyer in a sale transaction, but we cannot assure you that we will succeed in obtaining the services to which they relate at the same or better levels, or at the same or lower costs, directly from third party providers. The TSA is important to us, allowing us to construct business infrastructure that is appropriate to our needs as a stand-alone business without disrupting