B.C. Reg. 98/2026, deposited June 16, 2026, under the HEALTH PROFESSIONS AND OCCUPATIONS ACT [section 27]. Ministerial Order M237/2026, dated May 22, 2026.

I, Josie Osborne, Minister of Health, order that the Regulated Health Practitioners Regulation, B.C. Reg. 129/2025, is amended as set out in the attached Schedule.

— J. OSBORNE, Minister of Health.

Schedule

1 Section 15 of the Regulated Health Practitioners Regulation, B.C. Reg. 129/2025, is repealed and the following substituted:

Exemption for wearable hearing instruments

15 (1) In the case of a wearable hearing instrument that is software, "accompanying instrument" means, for the purposes of this section, an instrument referred to in paragraph (a.1) (ii) of the definition of "wearable hearing instrument".

(2) A person who is not otherwise authorized under the Act to dispense a wearable hearing instrument may make or sell wearable hearing instruments while engaged in the business of making or selling, on a wholesale basis, wearable hearing instruments.

(3) A person who is not otherwise authorized under the Act to dispense a wearable hearing instrument may sell a wearable hearing instrument if all of the following conditions are met:

(a) the wearable hearing instrument or, if applicable, any accompanying instrument, operates through air conduction;

(b) the innermost end of the wearable hearing instrument or, if applicable, any accompanying instrument, is designed, when inserted into the external ear canal, to remain at least 10 mm from the tympanic membrane;

(c) the user of the wearable hearing instrument is able to adjust and control the volume of the wearable hearing instrument or, if applicable, any accompanying instrument, with the maximum output being

(i) 111 dB SPL, or

(ii) 117 dB SPL while the inputcontrolled compression feature, if any, is activated;

(d) the wearable hearing instrument and, if applicable, any accompanying instrument, is the subject of a Class II Medical Device Licence issued under the Food and Drugs Act (Canada);

(e) the wearable hearing instrument and, if applicable, any accompanying instrument,

(i) is designed and marketed for persons aged 18 or older who have mild to moderate hearing loss, and

(ii) is not intended for use by any particular individual.

(4) For certainty, a person who sells a wearable hearing instrument that meets the conditions set out in subsection (3) does not perform the restricted activity of fitting a wearable hearing instrument by reason only that the wearable hearing instrument is equipped with a feature that enables the wearable hearing instrument

(a) to perform a standardized electronic assessment of hearing, and

(b) to automatically adapt the operation of the wearable hearing instrument for the user based on the assessment results.

2 Section 3 of the Schedule of Restricted Activities is amended

(a) in the definition of "wearable hearing instrument" by striking out "and" at the end of paragraph (a) (ii) and by adding the following paragraph:

(a.1) means software that is

(i) designed or offered for a hearing condition, and

(ii) designed to be used in combination with an instrument that is wearable on the head or body, whether the software is installed on the instrument or on a device with which the instrument is paired, and , and

(b) by adding the following subsection:

(3) For certainty, the instrument referred to in paragraph (a.1) (ii) of the definition of "wearable hearing instrument" is deemed to be an accessory to the wearable hearing instrument for the purposes of the performance of the restricted activity of inserting an instrument or device into the external ear canal.

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