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Hearing Aid, Air Conduction With Wireless Technology

Page Type
Product Code
Definition
Wireless hearing aids are intended as acoustic amplification devices for hearing impaired users.
Physical State
The device is worn behind-the-ear or in-the-canal with audio output into the ear supported by an ear canal mold.
Technical Method
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.
Target Area
The outer ear and the ear canal.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
874.3305
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.3305 Wireless air-conduction hearing aid

§ 874.3305 Wireless air-conduction hearing aid.

(a) Identification. 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.

(b) Classification: Class II (special controls). The special controls for this device are:

(1) Appropriate analysis/testing should validate electro magnetic compatibility (EMC) and safety of exposure to non-ionizing radiation;

(2) Design, description, and performance data should validate wireless technology functions; and

(3) Labeling should specify appropriate instructions, warnings, and information relating to EMC and wireless technology and human exposure to non-ionizing radiation.

(c) Premarket notification. The wireless air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

[76 FR 34846, June 15, 2011]

Hearing Aid, Air Conduction With Wireless Technology

Page Type
Product Code
Definition
Wireless hearing aids are intended as acoustic amplification devices for hearing impaired users.
Physical State
The device is worn behind-the-ear or in-the-canal with audio output into the ear supported by an ear canal mold.
Technical Method
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.
Target Area
The outer ear and the ear canal.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
874.3305
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.3305 Wireless air-conduction hearing aid

§ 874.3305 Wireless air-conduction hearing aid.

(a) Identification. 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.

(b) Classification: Class II (special controls). The special controls for this device are:

(1) Appropriate analysis/testing should validate electro magnetic compatibility (EMC) and safety of exposure to non-ionizing radiation;

(2) Design, description, and performance data should validate wireless technology functions; and

(3) Labeling should specify appropriate instructions, warnings, and information relating to EMC and wireless technology and human exposure to non-ionizing radiation.

(c) Premarket notification. The wireless air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

[76 FR 34846, June 15, 2011]