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.