SUBCHAPTER 22I ‑ PROFESSIONAL AFFAIRS
21 NCAC 22I .0101 CLIENTS' INTEREST
In order to serve the best interest of the client, all licensees and registered apprentices shall advise their clients to take the recommended actions as prescribed in 21 CFR 801 (effective August 15, 1977), Subparts 801.420 and 801.421, which are herein adopted by reference in accordance with G.S. 150B‑14 (b).
History Note: Authority G.S. 93D‑3(c); 150B‑14;
Eff. April 23, 1976;
Amended Eff. May 1, 1988;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. September 6, 2016.
History Note: Authority G.S. 93D‑3;
Eff. April 23, 1976;
Repealed Eff. May 1, 1988.
21 NCAC 22I .0103 VISUAL INSPECTION AND HEARING TEST
(a) All licensees and registered apprentices shall make a visual inspection of the external auditory canal and the tympanic membrane, using a device having its own light source in order to fulfill the requirements of 21 CFR 801.420 concerning the warning to hearing aid dispensers.
(b) All licensees and registered apprentices shall conduct a hearing test using an audiometer, the calibration for which is on file at the Board office, or equivalent physiologic testing.
(c) A hearing test shall be conducted within six months prior to the dispensing of a hearing aid and a copy of the hearing test shall be maintained for a period of at least three years.
(d) The hearing test shall be conducted in an environment conducive to obtaining accurate results and shall include the following, unless physiologic testing is utilized:
(1) live voice or recorded voice speech audiometry, including speech reception threshold testing and speech discrimination testing; and
(2) pure tone audiometry, including air conduction testing and bone conduction testing as follows:
(A) air conduction testing at least at the following frequencies: 500 Hz, 1000 Hz, 2000 Hz, 3000Hz, and 4000 Hz;
(B) mid-octave air conduction testing performed when there is a 20 dB or greater difference between any adjacent octaves;
(C) bone conduction testing at least at the following frequencies: 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz; and
(D) effective masking, if audiometric testing reveals a difference between the ears at any one frequency equal to or greater than 40 decibels or if there is audiometric air-bone gap of 15 dB or greater.
(e) All licensees and registered apprentices shall evaluate dispensed products to determine effectiveness and shall maintain documentation of the verification for a period of at least three years. Measures of evaluation shall include at least one of the following:
(1) sound field measurements;
(2) real ear measurements; or
(3) client evaluation sheets.
History Note: Authority G.S. 93D-1.1; 93D‑3(c);
Eff. April 23, 1976;
Amended Eff. January 1, 2015; November 1, 2013; April 1, 2013; April 1, 1989; May 1, 1988;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. September 6, 2016.
21 NCAC 22I .0104 MEDICAL REFERRAL
21 NCAC 22I .0105 MEDICAL REFERRAL OF OTHER HEARING PROBLEMS
History Note: Authority G.S. 93D‑3; 150B‑14;
Eff. April 23, 1976;
Repealed Eff. May 1, 1988.
21 NCAC 22I .0106 DISCLOSURE
(a) In addition to the information required by G.S. 93D‑7, all licensees and registered apprentices shall, by the time of delivery of the hearing aid(s), complete one or more written statements of sale containing the following:
(1) The business name and street address, within the State of North Carolina, of at least one place of business of the seller;
(2) The name of the person delivering the hearing aid(s) and the name of the person who sold the hearing aid(s);
(3) The name of the purchasing party, if different from the name of the consumer;
(4) The date of sale, if different from the date of delivery;
(5) The model of the hearing aid(s);
(6) The total cost to the purchaser for all products and services; and
(7) The serial number of the hearing aid(s).
(b) A copy of all statements of sales shall be retained for a period of three calendar years from the date of delivery of the hearing aid(s).
History Note: Authority G.S. 93D‑3(c);
Eff. April 23, 1976;
Amended Eff. January 1, 1992; May 1, 1988;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. September 6, 2016.
21 NCAC 22I .0107 AUDIOMETERS
History Note: Authority G.S. 93D‑3;
Eff. April 23, 1976;
Repealed Eff. May 1, 1988.
21 NCAC 22I .0108 CALIBRATION CHECK FOR AUDIOMETERS
(a) All audiometers used in the fitting and selling of hearing aids shall have an annual calibration check and be recalibrated, if necessary, in accordance with the standards cited in Rule .0010 of this Subchapter.
(b) Whenever any individual applies for issuance or renewal of a license or an apprentice registration certificate, the Board shall require proof of audiometer calibration within the 12 consecutive months preceding such application.
(c) If any individual applying for annual renewal of a license provides the Board with an affidavit from the applicant that the applicant is not engaged in or being compensated for any activity requiring a North Carolina license to fit and sell hearing aids, the Board shall waive the annual renewal requirement cited in Paragraph (b), for up to three consecutive renewal years. If granted this waiver, the individual shall not engage in or be compensated for any activity requiring a North Carolina license to fit and sell hearing aids until the individual has furnished the Board with proof of audiometer calibration occurring within the preceding 12 consecutive months.
History Note: Authority G.S. 93D‑3(c);
Eff. April 23, 1976;
Amended Eff. March 1, 1996; April 1, 1989; May 1, 1988;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. September 6, 2016.
21 NCAC 22I .0109 APPROVAL OF CALIBRATERS
The Board shall not accept calibration records from any individual or calibration center unless such individual or center is registered with the Board and has performed the calibration in accordance with Rule .0010 of this Subchapter. Manufacturers of audiometers may calibrate without registering with the Board. A list of registered individuals and centers, as well as the form used to apply to become a registered calibrater, may be obtained from the office of the Board.
History Note: Authority G.S. 93D‑3(c);
Eff. April 23, 1976;
Amended Eff. March 1, 1996; May 1, 1988;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. September 6, 2016.
21 NCAC 22I .0110 STANDARDS FOR AUDIOMETERS
All audiometers used for fitting and selling hearing aids shall be in calibration according to the standards contained in the ANSI S3.6‑1969 specifications for audiometers which are herein adopted by reference, in accordance with G.S. 150B‑14 (b).
History Note: Authority G.S. 93D‑3(c); 150B‑14;
Eff. April 23, 1976;
Amended Eff. May 1, 1988;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. September 6, 2016.
21 NCAC 22I .0111 SYMBOLS FOR AUDIOGRAMS
(a) The Board recommends that the following standard symbols be used in recording hearing thresholds:
(1) Right ear unmasked will be denoted as follows:
(A) air ‑‑ a small circle;
(B) bone ‑‑ a 45 degree angle pointing left.
(2) Left ear unmasked will be denoted as follows:
(A) air ‑‑ a small "x";
(B) bone ‑‑ a 45 degree angle pointing right.
(3) Right ear masked will be denoted as follows:
(A) air ‑‑ a small triangle;
(B) bone ‑‑ a single bracket open on the right.
(4) Left ear masked will be denoted as follows:
(A) air ‑‑ a small square;
(B) bone ‑‑ a single bracket open on the left.
(5) No response for the right ear at the maximum output of the audiometer will be denoted by a small arrow pointing southwest which is attached to the corresponding unmasked and masked symbols.
(6) No response for the left ear at the maximum output of the audiometer will be denoted by a small arrow pointing southeast which is attached to the corresponding unmasked and masked symbols.
(7) An asterisk will denote the contralateral ear masked.
(8) A capital "S" will denote sound field responses.
(b) In all cases where the symbols listed in this Rule are not used, a symbol key shall be included on the audiogram form.
History Note: Authority G.S. 93D‑3(c);
Eff. April 23, 1976;
Amended Eff. May 1, 1988;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. September 6, 2016.
21 NCAC 22I .0112 DISPLAY OF PRINTED CERTIFICATES
Pursuant to G.S. 93D‑12, all licensees and registered apprentices shall have a street address, located within the State of North Carolina, at which they display their license or apprentice registration certificate. In addition, all licensees and registered apprentices shall carry with them a copy of their license or apprentice registration certificate, or their pocket identification card issued by the Board, when doing business which takes them outside of their offices.
History Note: Authority G.S. 93D‑3(c); 93D‑12;
Eff. April 23, 1976;
Amended Eff. May 1, 1988;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. September 6, 2016.
21 NCAC 22I .0113 LOCATION FOR PROVISION OF SERVICE
(a) Service after sale is a consumer's right and all licensees and registered apprentices shall furnish to each hearing aid purchaser, in writing, at least one business address within the State of North Carolina where service and fulfillment of guarantees can be obtained. This information shall be given to the purchaser by the time of delivery of the hearing aid(s).
(b) A post office box shall not suffice for the business address referred to in Paragraph (a) of this Rule and the address of any hearing aid manufacturer, distributor, or repair facility, located outside the State of North Carolina, shall not suffice for this required address. In addition, the address of any hearing aid manufacturer or repair facility within the State of North Carolina shall not suffice for the referenced address, unless the licensee or registered apprentice who is the seller of the hearing aid(s) is also the owner or an employee of such facility.
History Note: Authority G.S. 93D‑3(c);
Eff. April 23, 1976;
Amended Eff. May 1, 1988;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. September 6, 2016.
21 NCAC 22I .0114 CHANGE OF ADDRESS
All individuals regulated by the Board shall provide the Board with current address information by completing the online address change form available on the Board's website (www.nchalb.org) within 14 days of any change in mailing address or name and street address of any business within the State of North Carolina. Failure to do so may result in disciplinary action after proper notice and hearing.
History Note: Authority G.S. 93D-3(c); 93D-10; 93D-13
Eff. April 23, 1976;
Amended Eff. February 1, 1996; May 1, 1988;
Recodified from 21 NCAC 22F .0118 Eff. May 1, 2013;
Amended Eff. December 1, 2014;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. September 6, 2016.