Over-the-Counter (OTC) Hearing Aids and Professional Obligations

The Alberta College of Speech-Language Pathologists and Audiologists (ACSLPA) would like to thank the ACSLPA over-the-counter (OTC) hearing aids ad-hoc committee members for their time and participation on this committee, and the ACSLPA members who took time to share their expertise and provide thoughtful review and revisions to this advisory statement.

OTC hearing aids are air-conduction hearing aids that amplify sound into the ear canal and do not require surgical intervention, or hearing healthcare professionals’ involvement. OTC hearing aids are intended for use by individuals 18 years of age and older, to help with perceived mild to moderate hearing loss (FDA, 2022) and are considered direct-to-consumer (DTC) hearing devices.

This advisory statement addresses the minimum professional and ethical obligations of the registered audiologist, by addressing ACSLPA’s Standards of Practice (SoP), Code of Ethics (CoE) and other Key College Documents in the context of OTC hearing aids with individuals over 18 years of age.

It is ACSLPA’s position that over-the-counter (OTC) hearing aids are not intended for and are inappropriate for use by individuals under 18 years of age. ACSLPA recognizes the risk of harm from pediatric use of OTC hearing aids. For more information, please refer to ACSLPA’s Over-the-Counter (OTC) Hearing Aids and Pediatrics Position Statement.

For the purpose of this document, prescription hearing aids are defined as hearing aids that are custom‑fitted and programmed based on a comprehensive hearing assessment. They may be fitted for any degree of hearing loss and for clients of any age and are typically only available through regulated hearing care providers. Although this differs from province to province, in Alberta, a prescription is not required to obtain these devices.

This advisory statement provides direction to ensure registered speech-language pathologists (SLP) and audiologists have information to comply with legislation, standards and minimum requirements as they relate to OTC hearing aids. This document utilizes the following icon:

Regulation of OTC Hearing Aids

The Medical Devices Directorate (MDD) of Health Canada regulates both OTC and prescription hearing aids as Class II medical devices under the Canadian Medical Devices Regulation (MDR). Medical devices are classified into four classes, where Class I is considered to carry the lowest potential risk, and Class IV is considered to carry the greatest potential risk. Class II medical devices, including OTC and prescription hearing aids, are considered to carry a moderate level of potential risk, and require a medical device licence before they can be sold in Canada. Health Canada has been licensing specific OTC hearing aids. You can search and verify Health Canada’s license approvals of OTC hearing aids, using the company, licence name or device identifier etc. at the following link: https://health-products.canada.ca/mdall-limh/prepareSearch?type=active.

To receive approval, manufacturers of OTC hearing aids must attest that the product meets the current standards established by the MDR. However, these standards do not outline specific details related to OTC hearing aids, including acoustic or amplification requirements. The current standards pertain to quality management, design and manufacturing, the integrity and compatibility of materials, device performance for its intended purpose, and packaging and labeling. Health Canada’s list of recognized standards for medical devices is available on their website.

All approved Class II diagnostic and therapeutic medical devices are monitored and evaluated by the MDD to ensure ongoing safety, effectiveness, and quality. The MDD monitors medical devices through recalls, complaints and problem reports from consumers, health care professionals, interested parties and other sources. Regulated members are encouraged to report problems or concerns with approved medical devices to Health Canada online or by calling 1-800-267-9675. Examples of concerns may include, but are not limited to, malfunctioning, reduced effectiveness over time, difficulty of use, unclear instructions, and potential or actual harm.

Alberta’s Health Professions Act (HPA):

Regulations and laws governing the professions of audiology and speech-language pathology and the fitting and dispensing of hearing aids differ across Canadian provinces and territories.

In Alberta, audiologists and speech-language pathologists (SLPs) are regulated under the Health Professions Act (HPA). Hearing Aid Practitioners are also regulated under the HPA by the College of Hearing Aid Practitioners of Alberta (CHAPA). There is no legislation in Alberta, including the HPA, that governs or regulates the sale of hearing aids, whether OTC or prescription.

The HPA provides legislative guidance by defining an audiologist’s area of practice (i.e., practice statement), authorizing regulated health professionals in Alberta to perform restricted activities, and protecting the use of professional titles. Audiologists who comply with the HPA, ACSLPA’s Standards of Practice, and Code of Ethics may provide and fit approved OTC hearing aids when appropriate for their clients.

Providing devices, including OTC hearing aids, to treat auditory dysfunction is not a restricted activity under the HPA. Therefore, individuals who are not regulated members of a health profession college may fit or dispense OTC hearing aids in Alberta. Restricted activities such as ‘inserting or removing a device beyond the cartilaginous portion of the ear canal’ or ‘inserting into the ear canal a substance that subsequently solidifies’ must be performed by authorized regulated health professionals in Alberta, including registered audiologists. Notably, in Alberta these restricted activities are not exclusive to registered audiologists.

As part of its mandate, under the HPA, ACSLPA has a role with respect to OTC hearing aids. The College is responsible for establishing, maintaining and enforcing Standards of Practice, a Code of Ethics and regulatory guidance to ensure competent, safe, and ethical practice of regulated members when working in the context of OTC hearing aids. ACSLPA does not regulate the availability of OTC hearing aids, or the technical standards for OTC or prescription hearing aids.

The College supports increasing access to hearing health solutions for Albertans, while it also recognizes the importance of ensuring public safety, education and product efficacy. As part of ACSLPA’s focus on public safety, the College has a position statement asserting that OTC hearing aids are not intended for and are inappropriate for individuals under 18 years of age.

In this section, the advisory statement aims to highlight the current guidance available through ACSLPA’s Standards of Practice, Code of Ethics and Key College Documents that should inform regulated members’ practice in their work with adult clients and OTC hearing aids. Please note, this guidance is not exhaustive; additional College documents not explicitly highlighted in this advisory statement may also be applicable to OTC hearing aids.

The guidance is separated into three following areas:

• Client-Centered Service and Informed Choice
• Audiology Practice Considerations
• Risk Management

Collaboration

Regulated members are expected to involve and collaborate with clients in all decision-making related to service provision (SoP 1.1, 1.4, 1.5 and CoE 3.0). This includes those clients who are using or considering OTC hearing aids as an intervention. In potentially challenging situations, where a client may opt for OTC hearing aids instead of the professional recommendation provided to them, regulated members need to respect the client’s autonomy and right to choose service options, refuse recommendations or interventions, and withdraw consent at any time (SoP 2.3(d) and CoE 1.0).

Audiologists should also work collaboratively with other relevant health service providers, who may be involved with the client to facilitate an integrated approach (SoP 1.5 and CoE 4.0). It is the regulated member’s responsibility to serve as an educator and advocate, when appropriate, by liaising with the client, families and other professionals (SoP 1.5(d)(e), 1.3(j)). They should know and be prepared to explain their scope of practice and the suitability of various hearing healthcare interventions (SoP 1.5(f)).

Informed Consent and Decision Making

As with all aspects of service delivery, informed consent is required prior to any screening/assessment or intervention. Clients need to be made aware of the potential risks, benefits and alternatives for any proposed service or intervention, including interventions chosen by the client, such as OTC hearing aids (SoP 2.3(a)). The audiologist’s clinical judgement should inform their explanation of the benefits, risks, and alternatives relevant for the client and support informed decision-making. The regulated member should also disclose their own level of knowledge or familiarity and competence with respect to OTC hearing aids. Please refer to the ‘Competence’ section below for more information.

It is a requirement to clearly and accurately document discussions, recommendations, explanations, and client decisions (SoP 4.3). It may be prudent for regulated members, working with clients using or considering OTC hearing aids, to establish formalized and tailored consent procedures that asks the client to acknowledge and accept their understanding, recommendations and potential risks or limitations that were discussed and their decision to proceed. Notably, limitations may include those of the OTC hearing aid. Please refer to ACSLPA’s Clinical Documentation and Record Keeping Guideline (2021) for information related to documentation, record management and retention requirements.

Counselling, Education and Advocacy

Regulated members have a professional and ethical responsibility to provide balanced, evidence-informed education and counselling to clients regarding hearing healthcare options, including OTC hearing aids, using a client-centered approach that respects individual needs, values and goals, and supports informed decision-making (SoP 1.1, 1.2 and 2.3). This encompasses staying current on the benefits, risks and technology related to OTC hearing aids, if relevant to an audiologist’s practice. In doing so, there should be consideration and use of a variety of communication strategies, styles, and language, appropriate for the client. Audiologists should also incorporate principles of cultural safety and health literacy in their counselling approach (SoP 1.4(a)(b)).

Encourage, assess and confirm the client’s understanding of the suitability, risks, benefits, limitations and alternatives that may be available to them in relation to OTC hearing aids, by allowing open, two-way dialogue (SoP 1.4, 2.3). Audiologists are well-positioned to provide guidance on the regulatory frameworks in Alberta and Canada and clinical considerations with respect to OTC hearing aids. Clients and the public may benefit from their audiologist proactively addressing OTC hearing aids as part of hearing solution discussions. This is aimed at promoting transparency, supporting  informed decision-making and educating the public in understanding the appropriateness of OTC hearing aids for their needs. Referring to reputable sources such as ACSLPA Key College Documents, and SAC’s Position Statement may be supportive to both the regulated member’s recommendations, and the client’s understanding.

Assessment and Intervention

A regulated member’s clinical judgment, and ability to accurately analyze and interpret information to determine an appropriate diagnosis or intervention, is supported by accurate and comprehensive assessment results (SoP 1.3(e)). A thorough hearing assessment ensures safe, effective, and individualized care, supporting the identification of underlying conditions, appropriate intervention selection, and avoidance of misdiagnosis or inappropriate device use, thereby enabling best clinical judgment and optimal client outcomes.

There may be situations where a client presents at a clinic with OTC hearing aids, without reliable or informative assessment results, but is requesting audiological support. Where appropriate, the regulated member should support the client within their knowledge and competence in the area of OTC hearing aids. The regulated member may recommend completing an audiological evaluation in the interest of providing a quality, safe, and ethical service and to avoid misdiagnosis, or inappropriate amplification and management. The regulated member needs to incorporate an evidence-informed approach by ensuring an assessment of the client’s priorities and needs, and any limitations or risks relevant to the client (SoP 1.2, 1.3(a)(b)). This should inform appropriate screening/assessments and interventions and identify any contraindications to OTC hearing aid use (SoP 1.2, 1.3(a)(b)). The reasons why the audiological evaluation is necessary, and all clinical considerations, including the client’s priorities, associated fees, the potential outcomes of evaluation such as the OTC hearing aids being unsuitable etc., need to be clearly communicated and documented prior to proceeding (SoP 1.3, 2.3, 4.7).

Competence

Having an awareness of what is defined under an audiologist’s practice statement in the HPA, as well as the audiologist’s knowledge and competence limitations, is important in maintaining and/or enhancing competence in new areas of practice through learning activities (SoP 1.3(b), 3.1). Clients and families may ask audiologists to work with OTC hearing aids or a manufacturer that they are unfamiliar with. If an audiologist determines they lack the competencies to provide safe and competent services for the client, they should disclose their concerns, and may limit their practice and/or discontinue services (SoP 3.1(b)). This could be a temporary or ongoing measure, and as the regulated member develops the necessary competencies these services may be introduced (SoP 3.1(b)).

When appropriate and suitable for the client, a regulated member may discuss and offer alternative products/services that they have knowledge and competence in. Facilitating and implementing discharge planning and access to alternative services when appropriate helps ensure the client remains well supported (SOP 1.3(i)(j),CoE 1.0).

Fees and Billing

Providing professional services and clinical expertise to clients with OTC hearing aids who request support may be reasonably and justifiably billed for (SoP 4.7). Fees for OTC hearing aid related products/services must be fully disclosed, including assessment and intervention, reports, equipment, and any other associated costs and consented to by the client, prior to service delivery (SoP 4.7(b)(c)).

Safety

Adhering to safe equipment-handling practices and infection-prevention and control standards remains applicable when working with clients and OTC hearing aids (SoP 4.1(e)). Equipment used when working with OTC hearing aids is also subject to maintenance and calibration requirements. This ensures compliance with manufacturer standards, client health and safety, and accuracy of assessment or intervention results. Please refer to ‘equipment service records’ in ACSLPA’s Clinical Documentation and Record Keeping Guideline for more information relating to equipment and documentation requirements.

Adverse Events and Reporting

Medical conditions and contraindications to OTC hearing aid use need to be appropriately identified, managed and documented, including referrals to other health care providers, as required (SoP 1.3(b)(j)). A regulated member needs to respond to adverse events in relation to a product or equipment, where they may be involved with a client using an OTC hearing aid (SoP 4.1(d)). Adverse events may include over or under amplification, device malfunction, technology performance issues, inappropriate use, manufacturing defects etc. While an audiologist may not be directly involved with the cause of an adverse event, they have an ethical responsibility to address issues of concern which may have an impact on the wellbeing of clients (CoE 4.8). Complying with ACSLPA’s Standards of Practice and Code of Ethics, and provincial legislation requirements, supports transparent, accountable service delivery and decision making. Problems or concerns with medical devices should be reported to Health Canada and manufacturers (refer to Regulatory Background section above).