# K103594: Ponto Pro Power

- Pathway: 510(k) (Traditional)
- Applicant: Oticon Medical AB
- Decided: Jun 15, 2011 after 189 days
- Product code: LXB (Hearing Aid, Bone Conduction)
- Device class: 2
- Regulation: 21 CFR 874.3302
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K861971 (1986). 19 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082108: Obc Bone Anchored Hearing Aid System, Oticon Medical AB (2008) Summary page 1.
- K090996: Ponto Pro, Oticon Medical AB (2009) Summary page 1.
- K090720: Cochlear Baha BP100, Cochlear Bone Anchored Systems AB (2009) Summary page 1.
- K081606: Baha Intenso, Cochlear Americas (2008) Summary page 1.

## Most influential descendants
- K132775: Ponto Plus and Ponto Plus Power (2013), 10 descendants of its own
- K161671: Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (2016), 5 descendants of its own
- K190540: Ponto 4 (2019), 3 descendants of its own
- K142678: Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm (2015), 3 descendants of its own
- K211640: Ponto 5 Mini (2021), 2 descendants of its own

## Indications for use
The Ponto Pro Power is intended for the following patients and indications: Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold of the indicated ear should be better than or equal to 55 dB HL (measured at 0.5, 1, 2 and 3 kHz). Bilateral fitting is applicable for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies. Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single-sided deafness or “SSD”). The pure tone average (PTA), air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. The placement of a bone anchored implant is contraindicated for patient below the age of 5. The Ponto Pro Power sound processor is intended to be connected to the Oticon Medical bone anchored implant system or to the Baha® Abutment snap coupling from Cochlear Bone Anchored Solutions AB (ref no. 90410, 90305, 90434, 90480).

Source page: https://510kreport.com/device/K103594
Methodology: https://510kreport.com/methodology