# K090996: Ponto Pro

- Pathway: 510(k) (Traditional)
- Applicant: Oticon Medical AB
- Decided: Jul 29, 2009 after 112 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: 5 generations back to K861971 (1986). 9 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 28 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.
- K042017: Baha Divino, Entific Medical Systems, Inc. (2004) Summary page 1.
- (no number) Air conduction hearing aids with digital sound processing: named in the summary without a submission number

## Most influential descendants
- K103594: Ponto Pro Power (2011), 11 descendants of its own
- 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
- K100193: Otomag Bone Conduction Hearing System (2010), 5 descendants of its own
- K102199: Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M) (2011), 4 descendants of its own

## Indications for use
The Ponto Pro is intended for the following patients and indications; * Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2 and 3 kHz). * Bilateral fitting is applicable for most 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, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). The placement of a bone anchored implant is contraindicated for patients below the age of 5. The Ponto Pro sound processor is intended to be connected to the Oticon Medical bone anchored implant system or to the Baha® Abutment snap coupling from Cochlear BAS. In addition, the Oticon Medical abutments can be used for connection of the Baha® sound processors with snap coupling from Cochlear BAS (Baha Divino®, Baha IntensoTM, Baha Cordelle II, Baha BP100).

Source page: https://510kreport.com/device/K090996
Methodology: https://510kreport.com/methodology