§800.30. Over-the-counter hearing aid controls. — Inbound Citations

(a) This section specifies the labeling requirements for prescription hearing aids. Any hearing aid that does not satisfy the requirements of § 800.30 of this chapter shall be a prescription device. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation in part 874 of this chapter. This section does not apply to group auditory trainers.

(a) An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.

(a) A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. A wireless air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.

(a) A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.

(a) This section specifies the requirements for over-the-counter (OTC) air-conduction hearing aids. Air-conduction hearing aids that satisfy the requirements in paragraphs (c) through (f) of this section are considered “available” over the counter as section 520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the term. Air-conduction hearing aids that do not meet the definition in section 520(q) of the Federal Food, Drug, and Cosmetic Act or do not satisfy the following requirements are prescription hearing aids. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation in part 874 of this chapter.

(5) OTC hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations (e.g., outside package labeling) specified in paragraphs (c)(1) through (4):

(i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step:

(B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers.

(ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user:

(A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it.

(B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step.

(C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step.

(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.

(iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step.

(v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it.

(5) OTC hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations (e.g., outside package labeling) specified in paragraphs (c)(1) through (4):

(i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step:

(B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers.

(ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user:

(A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it.

(B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step.

(C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step.

(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.

(iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step.

(v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it.

(5) OTC hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations (e.g., outside package labeling) specified in paragraphs (c)(1) through (4):

(i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step:

(B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers.

(ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user:

(A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it.

(B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step.

(C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step.

(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.

(iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step.

(v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it.

(5) OTC hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations (e.g., outside package labeling) specified in paragraphs (c)(1) through (4):

(i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step:

(B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers.

(ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user:

(A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it.

(B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step.

(C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step.

(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.

(iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step.

(v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it.

(5) OTC hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations (e.g., outside package labeling) specified in paragraphs (c)(1) through (4):

(i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step:

(B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers.

(ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user:

(A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it.

(B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step.

(C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step.

(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.

(iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step.

(v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it.

(5) OTC hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations (e.g., outside package labeling) specified in paragraphs (c)(1) through (4):

(i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step:

(B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers.

(ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user:

(A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it.

(B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step.

(C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step.

(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.

(iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step.

(v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it.

(5) OTC hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations (e.g., outside package labeling) specified in paragraphs (c)(1) through (4):

(i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step:

(B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers.

(ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user:

(A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it.

(B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step.

(C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step.

(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.

(iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step.

(v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it.

(5) OTC hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations (e.g., outside package labeling) specified in paragraphs (c)(1) through (4):

(i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step:

(B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers.

(ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user:

(A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it.

(B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step.

(C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step.

(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.

(iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step.

(v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it.

(5) OTC hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations (e.g., outside package labeling) specified in paragraphs (c)(1) through (4):

(i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step:

(B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers.

(ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user:

(A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it.

(B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step.

(C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step.

(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.

(iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step.

(v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it.

(a) This section specifies the requirements for over-the-counter (OTC) air-conduction hearing aids. Air-conduction hearing aids that satisfy the requirements in paragraphs (c) through (f) of this section are considered “available” over the counter as section 520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the term. Air-conduction hearing aids that do not meet the definition in section 520(q) of the Federal Food, Drug, and Cosmetic Act or do not satisfy the following requirements are prescription hearing aids. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation in part 874 of this chapter.

(a) This section specifies the requirements for over-the-counter (OTC) air-conduction hearing aids. Air-conduction hearing aids that satisfy the requirements in paragraphs (c) through (f) of this section are considered “available” over the counter as section 520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the term. Air-conduction hearing aids that do not meet the definition in section 520(q) of the Federal Food, Drug, and Cosmetic Act or do not satisfy the following requirements are prescription hearing aids. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation in part 874 of this chapter.

(1) Test the output distortion of the OTC hearing aid as follows to ensure that it does not exceed the limit specified in paragraphs (e)(1)(i) through (iii) of this section.

(i) The total harmonic distortion plus noise shall not exceed 5 percent for output levels within one of the following sets of levels, depending on the test method:

(A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB SPL; or

(ii) You must measure the total harmonic distortion using a 500-Hz input tone with an analyzer that has a bandwidth at least as wide as the frequency limits of the OTC hearing aid.

(iii) You must measure the output distortion at the OTC hearing aid's maximum volume and the input sound level to the OTC hearing aid adjusted to produce the required outputs.

(1) Test the output distortion of the OTC hearing aid as follows to ensure that it does not exceed the limit specified in paragraphs (e)(1)(i) through (iii) of this section.

(i) The total harmonic distortion plus noise shall not exceed 5 percent for output levels within one of the following sets of levels, depending on the test method:

(A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB SPL; or

(ii) You must measure the total harmonic distortion using a 500-Hz input tone with an analyzer that has a bandwidth at least as wide as the frequency limits of the OTC hearing aid.

(iii) You must measure the output distortion at the OTC hearing aid's maximum volume and the input sound level to the OTC hearing aid adjusted to produce the required outputs.

(1) Test the output distortion of the OTC hearing aid as follows to ensure that it does not exceed the limit specified in paragraphs (e)(1)(i) through (iii) of this section.

(i) The total harmonic distortion plus noise shall not exceed 5 percent for output levels within one of the following sets of levels, depending on the test method:

(A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB SPL; or

(ii) You must measure the total harmonic distortion using a 500-Hz input tone with an analyzer that has a bandwidth at least as wide as the frequency limits of the OTC hearing aid.

(iii) You must measure the output distortion at the OTC hearing aid's maximum volume and the input sound level to the OTC hearing aid adjusted to produce the required outputs.

(a) This section specifies the requirements for over-the-counter (OTC) air-conduction hearing aids. Air-conduction hearing aids that satisfy the requirements in paragraphs (c) through (f) of this section are considered “available” over the counter as section 520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the term. Air-conduction hearing aids that do not meet the definition in section 520(q) of the Federal Food, Drug, and Cosmetic Act or do not satisfy the following requirements are prescription hearing aids. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation in part 874 of this chapter.