Oticon Ponto bone anchored hearing system

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

DEMANT SINGAPORE PTE LTD

Class:

Class C medical device

Manufactured by:

Oticon Medical AB

Therapeutic area:

Ear, Nose & Throat

Therapeutic indications:

The Ponto bone anchored hearing system is intended for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness.

Product summary:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], System of implants, accessories and sound processors. Implants, abutments and disposable surgical instruments are radiation sterilized; Models: Ponto Plus, L, DBL - M51700, Ponto Plus, R, DBL - M51701, Ponto Plus, L, MBR - M51702, Ponto Plus, R, MBR - M51703, Ponto Plus, L, CBE - M51704, Ponto Plus, R, CBE - M51705, Ponto Plus, L, WHS - M51706, Ponto Plus, R, WHS - M51707, Ponto Plus Demo, L, WHS - M51721, Ponto Plus Demo, R, WHS - M51722, Ponto Plus Power, L, DBL - M51730, Ponto Plus Power, R, DBL - M51731, Ponto Plus Power, L, MBR - M51732, Ponto Plus Power, R, MBR - M51733, Ponto Plus Power, L, CBE - M51734, Ponto Plus Power, R, CBE - M51735, Ponto Plus Power, L, WHS - M51736, Ponto Plus Power, R, WHS - M51737, Ponto Plus Power Demo, L, WHS - M51752, Ponto Plus Power Demo, R, WHS - M51753, Ponto Pro, left, chroma beige - 130-00-210-00, Ponto Pro, right, chroma beige - 130-00-220-00, Ponto Pro, left, mocca brown - 130-00-211-00, Ponto Pro, right, mocca brown - 130-00-221-00, Ponto Pro, left, diamond black - 130-00-212-00, Ponto Pro, right, diamond black - 130-00-222-00, Ponto Pro, left, white silver - 130-00-213-00, Ponto Pro, right, white silver - 130-00-223-00, Ponto Pro Power, right, diamond black - M50676, Ponto Pro Power, left, diamond black - M50677, Ponto Pro Power, right, mocca brown - M50872, Ponto Pro Power, left, mocca brown - M50873, Ponto Pro Power, right, chroma beige - M50874, Ponto Pro Power, left, chroma beige - M50875, Ponto Pro Power, right, white silver - M50902, Ponto Pro Power, left, white silver - M50903, BL Oticon Medical Streamer - 155372, WH Oticon Medical Streamer - 155373, Genie Medical - M50504, Soft band, pink, bilateral - M50734, Soft band, light blue, bilateral - M50735, Soft band, black, bilateral - M50736, Soft band, beige, bilateral - M50737, Soft band, navy blue, bilateral - M50738, Soft band, red, bilateral - M50739, Soft band, pink - M50551, Soft band, light blue - M50612, Soft band, black - M50637, Soft band, beige - M50638, Soft band, navy blue - M50639, Soft band, red - M50640, Head band - M50308, Test band - M50104, Xpress - M50006, Telecoil - M50446, Audio adapter - M50377, Wide implant, 4 mm, with Abutment, 6mm - M51136, Wide implant, 4 mm, with Abutment, 9 mm - M51137, Wide implant, 4 mm, with Abutment, 12 mm - M51138, Wide implant, 4 mm, with abutment, 14 mm - M52065, Wide implant, 4 mm - M51139, Wide implant, 3 mm, with Abutment, 6 mm - M51140, Wide implant, 3 mm, with Abutment, 9 mm - M51141, Wide implant, 3 mm - M51142, Ponto BHX Implant, 4 mm, with Abutment, 6 mm - M52168, Ponto BHX Implant, 4 mm, with Abutment, 9 mm - M52169, Ponto BHX Implant, 4 mm, with Abutment, 12 mm - M52170, Ponto BHX Implant, 4 mm, with Abutment, 14 mm - M52171, Ponto BHX Implant, 3 mm, with Abutment, 6 mm - M52166, Ponto BHX Implant, 3 mm, with Abutment, 9 mm - M52167, Ponto BHX Implant, 4 mm - M52173, Ponto BHX Implant, 3 mm - M52172, Abutment, 14 mm - M52063, Abutment, 12 mm - M51149, Abutment, 9 mm - M50318, Abutment, 6 mm - M50349, Angled abutment 10° - M50362, Cover screw hexagon - M50098, Counter torque wrench - M51690, Abutment inserter, machine - M51695, Screwdriver hexagon - M50534, Screwdriver, machine, 35mm - M50384, Square fit connection, machine - M50386, Sound processor indicator - M50428, Handle with screwdriver - M50437, Healing cap - M50821, Wide countersink, 3 mm - M51144, Wide countersink, 4 mm - M51122, Guide drill, 3-4 mm - M50287, Sterilization Cassette - M52074, Soft healing cap - M52080, Ruler - M52143, MIPS Surgery kit, 4 mm - M52207, MIPS Back-up kit, 3mm - M52329, Insertion indicator - M52366, Double-ended dissector - M52196, Abutment extension, 1 mm - M52321, Adapter, abutment extension - M52322, Ponto 3, L, DBL - M52620, Ponto 3, R, DBL - M52621, Ponto 3, L, MBR - M52622, Ponto 3, R, MBR - M52623, Ponto 3, L, CBE - M52624, Ponto 3, R, CBE - M52625, Ponto 3, L, WHS - M52626, Ponto 3, R, WHS - M52627, Ponto 3, L, STG - M52628, Ponto 3, R, STG - M52629, Ponto 3, L, PUW - M52630, Ponto 3, R, PUW - M52631, Ponto 3 Demo, L, CBE - M52632, Ponto 3 Demo, R, CBE - M52633, Ponto 3 Power, L, DBL - M52634, Ponto 3 Power, R, DBL - M52635, Ponto 3 Power, L, MBR - M52636, Ponto 3 Power, R, MBR - M52637, Ponto 3 Power, L, CBE - M52638, Ponto 3 Power, R, CBE - M52639, Ponto 3 Power, L, WHS - M52640, Ponto 3 Power, R, WHS - M52641, Ponto 3 Power, L, STG - M52642, Ponto 3 Power, R, STG - M52643, Ponto 3 Power, L, PUW - M52644, Ponto 3 Power, R, PUW - M52645, Ponto 3 SuperPower, L, DBL - M52648, Ponto 3 SuperPower, R, DBL - M52649, Ponto 3 SuperPower, L, MBR - M52650, Ponto 3 SuperPower, R, MBR - M52651, Ponto 3 SuperPower, L, CBE - M52652, Ponto 3 SuperPower, R, CBE - M52653, Ponto 3 SuperPower, L, WHS - M52654, Ponto 3 SuperPower, R, WHS - M52655, Ponto 3 SuperPower, L, STG - M52656, Ponto 3 SuperPower, R, STG - M52657, Ponto 3 SuperPower, L, PUW - M52658, Ponto 3 SuperPower, R, PUW - M52659, Ponto Soft band, beige - 173366, Ponto Soft band, yellow - 173367, Ponto Soft band, red - 173368, Ponto Soft band, pink - 173369, Ponto Soft band, cerise - 173379, Ponto Soft band, purple - 173380, Ponto Soft band, navy - 173381, Ponto Soft band, indigo - 173382, Ponto Soft band, blue - 173383, Ponto Soft band, turquoise - 173384, Ponto Soft band, green - 173385, Ponto Soft band, grey - 173386, Ponto Soft band, brown - 173387, Ponto Soft band, black - 173388, Ponto SoundConnector - 173391, Demo BL Oticon Medical Streamer - 155371, Connectline TV adapter - 124771, Connectline microphone - 108402, Safety line - M50029, Ponto Care Kit - M51177, Skull Simulator - SKS10, Ampoule holder - M50535, Ponto 3 SuperPower Demo, L, CBE - M52660, Ponto 3 SuperPower Demo, R, CBE - M52661, ConnectLine App for iOS (Apple) - ConnectLine App for iOS (Apple), ConnectLine App for Android - ConnectLine App for Android, Ponto Soft band, bilateral, beige - 185311, Ponto Soft band, bilateral, yellow - 185312, Ponto Soft band, bilateral, red - 185313, Ponto Soft band, bilateral, pink - 185314, Ponto Soft band, bilateral, cerise - 185315, Ponto Soft band, bilateral, purple - 185316, Ponto Soft band, bilateral, navy - 185317, Ponto Soft band, bilateral, indigo - 185318, Ponto Soft band, bilateral, blue - 185319, Ponto Soft band, bilateral, turquoise - 185320, Ponto Soft band, bilateral, green - 185321, Ponto Soft band, bilateral, grey - 185322, Ponto Soft band, bilateral, brown - 185323, Ponto Soft band, bilateral, black - 185324, MIPS Surgery kit, 4 mm - 192232, MIPS Back-up kit, 3mm - 192233

Authorization date:

2014-12-15