# K261142: Ponto 5 Mini; Ponto 5 Superpower

- Pathway: 510(k) (Special)
- Applicant: Oticon Medical AB
- Decided: Aug 26, 2026 after 141 days
- Product code: MAH (Hearing Aid, Bone Conduction, Implanted)
- 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: 12 generations back to K861971 (1986). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211640: Ponto 5 Mini, Oticon Medical AB (2021) Summary page 5.
- K213733: Ponto 5 SuperPower, Oticon Medical AB (2021) Summary page 5.

## Indications for use
The Ponto Implant system including Ponto sound processors 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 (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal 45 dB HL for Ponto 5 Mini or 65 dB HL for Ponto 5 SuperPower. • 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 (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 patients below the age of 5 years. The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

Source page: https://510kreport.com/device/K261142
Methodology: https://510kreport.com/methodology