Update on Over-the-Counter (OTC) Hearing Aids
RCASLPNB News
May 7, 2025
Update on Over-the-Counter (OTC) Hearing Aids and Frequently Asked Questions
The Regulatory College of Audiologists and Speech-Language Pathologists of New Brunswick (RCASLPNB) is responsible for regulating audiologists and speech-language pathologists in New Brunswick. Our role is to ensure that these professionals meet standards that prioritize patient care.
RCASLPNB is aware that in December 2024, Health Canada approved the Apple hearing test and hearing aid features for use in Canada with compatible software and the Airpod Pro 2 earbuds. In response, RCASLPNB has developed FAQs to address questions from members of the public about the availability of this new technology.
RCASLPNB does not have authority over devices or technology. We do not test or approve devices, features or products; nor do we regulate hearing aid companies or the clinics or entities where hearing aids are sold or dispensed. However, we provide guidance to audiologists on how to support residents of New Brunswick who may obtain over-the-counter hearing aids (“OTCs”) elsewhere, such as from the United States. This includes helping the public understand the benefits, risks, and limitations of hearing technology, alternative options, and ensuring that recommendations are patient-centred and evidence-informed.
RCASLPNB supports public access to safe, high-quality hearing technology. We are encouraged by the potential of new and innovative technology that may empower New Brunswickers to seek better hearing health. However, members of the public should be aware that OTC hearing aids are not suitable for everyone. For example, adults who experience ringing in their ears, problems with their balance, or sudden changes in their hearing, should seek assistance from an audiologist or a physician. Importantly, OTC hearing technologies are not recommended for treatment of hearing loss in infants and children. Audiologists play an important role in providing reliable and trustworthy information to the public about the risks and benefits of OTC hearing aids.
RCASLPNB is monitoring developments and collaborating with provincial regulators across Canada to assess how the approval of some over-the-counter (OTC) hearing devices by Health Canada might impact regulation of the professions in New Brunswick.
For questions, contact Nicole Fowler, RCASLPNB Registrar/Executive Director, at registrar@rcaslpnb.ca.
Practice Advice Statement: Over-The-Counter (OTC) and Other Non-Prescribed Hearing Aids
The following FAQs are for the public and will be revised as new information becomes available.
Frequenly Asked Questions
1. When will the Apple hearing aid and hearing test features be available in New Brunswick given that Health Canada has approved them? |
| RCASLPNB is not aware if, or when, the Apple hearing test and hearing aid features will become available in New Brunswick, or elsewhere in Canada. RCASLPNB can only regulate individual health professionals and cannot regulate devices or technologies entering the market. RCASLPNB also does not have legal authority over hearing aid companies or the clinics or shops where hearing aids may be dispensed or purchased. RCASLPNB recommends that hearing aids are dispensed with a prescription from an audiologist, physician or other regulated health professional, and only after a hearing and hearing aid candidacy assessment. This is because, in certain situations, there is risk of harm if people use hearing aids without a hearing examination or consultation with an audiologist. For example, if there is an unidentified medical issue underlying a hearing problem, when the hearing loss is severe, or for hearing loss involving children, a patient/client should seek assistance from a regulated health professional. It is recognized that OTC hearing devices, including Apple's features, are newer hearing technologies that are intended for adults 18 and older with perceived mild to moderate hearing loss and for self-guided use without a prescription. It is anticipated that the provincial government may need to consider how to enable access to this specific technology while maintaining safety standards for the public at large. |
2. Is RCASLPNB preventing public access to OTC hearing technologies, like the Apple features? |
| No, RCASLPNB is not preventing public access to OTC hearing technologies. RCASLPNB does not have the authority to regulate features or devices, or to make decisions that restrict or grant access to them. We do not approve or issue medical device licenses, including for the Apple hearing aid features or any hearing aids. RCASLPNB's role is to regulate the professional practice of audiologists and speech-language pathologists in accordance with provincial legislation, Standards of Practice, and Code of Ethics to protect the public. RCASLPNB has provided guidance to audiologists on how to assist the public with an OTC hearing device that may have been acquired outside of Canada. |
3. Are OTCs available in the U.S? |
| Yes. In 2022, the U.S. Food and Drug Administration (FDA) introduced a new category for over-the-counter (OTC) hearing aids for adults 18 and older with perceived mild to moderate hearing loss. This update created a pathway for OTC hearing aids in the United States, while maintaining an existing regulatory framework for prescription hearing aids for those who need them. This allows for OTC hearing technology to be available directly to the public in the U.S with requirements that safeguards be in place, such as clear labeling, to inform the public on when OTCs may be suitable or not. |
4. Are prescriptions important for hearing aids? |
| Yes. Hearing loss is not a "one-size-fits-all" condition. As mentioned in the first FAQ, there can be a risk of harm in some situations if people use hearing aids without a proper assessment of their hearing and without advice from a regulated audiologist. RCASLPNB recommends that individuals who are experiencing issues with their hearing speak with an audiologist or their physician, both regulated health professionals. The prescription process followed by audiologists ensures that a proper hearing assessment is conducted, that prescriptions address the needs and preferences of an individual, that conflict of interest is managed, and that follow-up is provided. |
5. What are the qualifications of audiologists? |
| Audiologists must meet the minimum educational requirement of a master's degree or substantial equivalent to be registered with RCASLPNB to practice in New Brunswick. Audiologists have knowledge, skills, judgement, and training to identify hearing loss and provide personalized treatment recommendations. This may include prescribing hearing aids, providing strategies for managing hearing loss, offering treatments like earwax removal, or referring a patient to a physician if there are red flags that suggest a medical concern (e.g., more hearing loss in one ear compared to the other, pain in the ears, dizziness or ringing in the ears). In some cases, an audiologist may recommend that a patient/client consult a physician if further investigation of their hearing loss is needed. |
6. What is the Regulatory College of Audiologists and Speech-Language Pathologists of New Brunswick (RCASLPNB)? |
| RCASLPNB is a self-governing professional regulatory body whose activities are directed by provincial legislation. No one may practice audiology or speech-language pathology in New Brunswick unless they are a registrant of RCASLPNB. RCASLPNB ensures public safety by regulating, supporting and ensuring the competent, safe and ethical practice of audiologists and speech-language pathologists in New Brunswick. RCASLPNB does not advocate for the professions or individual registrants. |
7. Where does RCASLPNB get its legal authority? |
| RCASLPNB operates under the Audiology and Speech-Language Pathology Act which is the legislation that authorizes and governs the regulation of the professions in New Brunswick. |
RCASLPNB acknowledges and thanks the College of Audiologists and Speech-Language Pathologists of Ontario (CASLPO) for allowing RCASLPNB to adapt their OTC hearing aids update and Practice Advice Statement.