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- 1 ) Chronic otitis media with effusion characterize as either serous, mucoid, or purulent. - 2) Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies. - 3) A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistent or recurrent otalgia, persistent or recurrent vertigo and/or timitus. - 4) Atelectasis recurrent form retraction pocket of the tympanic membrane or eustachian tube dysfunction.

The Grace Medical, Inc. ETFE (Fluoroplastic) Ventilation Tubes are intended to ventilate the middle ear subsequent to otitis media. The placement of the tympanic membrane provides the means for any fluid buildup in the middle ear while creating an avenue of the passage of air to equalize pressure on either side of the drum. These ventilation tubes will be made from ETFE (fluoroplastic). ETFE has been used as a material for ventilation tubes and other middle ear application for many years.

The DragonFly™ Surgical Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

The DragonFly™ Surgical Drill System consists of a small surgical power tool (handpiece); a battery powered footswitch for control of speed and direction; various cutting instruments (burs); angled adaptors to adjust the angle between the handpiece and the bur; and a sterilization tray. Accessories include a battery charger and a battery replacement kit.

An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include: (a) Chronic middle ear disease, (b) Otosclerosis, (c) Congenital fixation of the stapes, (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and (e) Surgically correctible injury to the middle ear from trauma.

The Grace Dynamic Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices: (i) Unalloyed titanium (ASTM F67) (ii) Titanium alloy (ASTM F136) (iii) Medical Grade Silicone (iv) ASTM F1185 Hydroxylapatite

An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include: (a) Chronic middle ear disease, (b) Otosclerosis. (c) Congenital fixation of the stapes, (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and (e) Surgically correctible injury to the middle ear from trauma.

The family of K-Helix Partial Ossicular Replacement Prostheses consists of: - K-Helix Piston - K-Helix PORP The Grace Medical Partial Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices: (i) Nitinol (ASTM F2063-05) (ii) Unalloyed titanium (ASTM F67) (iii) Titanium alloy (ASTM F136)

An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include: (a) Chronic middle ear disease, (b) Otosclerosis, (c) Congenital fixation of the stapes, (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and (e) Surgically correctible injury to the middle ear from trauma.

The family of Grace Medical Nitinol Partial Ossicular Replacement Prostheses consists of: Nitinol Locking Incudo-Stapedial Joint Nitinol Locking Angular Piston Nitinol Locking Piston Nitinol Locking Malleus Piston Nitinol Locking PORP Footplate Shoe. The prostheses are manufactured from Nitinol (ASTM F2063-05), Unalloyed titanium (ASTM F67), Titanium alloy (ASTM F136), Hydroxylapatite (ASTM F1185), Fluoroplastic (USP Class VI for plastics, ASTM D1710 and ASTM F754), and Medical grade silicone.

The Grace Medical PC Coated Tympanostomy Tubes have primary intended use as the predicate devices - A device that is intended to be implanted for ventilation or drainage of the middle ear. Indications for Use 1) (a) Chronic otitis media with effusion (serous, mucoid, or purulent). (b) Recurrent episodes of acute otitis media despite conventional medical treatment. (c) A record of persistent high negative middle ear pressure associated with one or more of the following svmptoms: (i) Conductive hearing loss that is symptomatic. (ii) Persistent or recurrent otalgia. (iii) Persistent or recurrent vertigo, tinnitus, or both. (d) Retraction pocket of the tympanic membrane.

The Grace Medical PC Coated Tympanostomy Tubes are manufactured from medical grade silicone. Each tube is coated with a layer of PC1036 phosphorylcholine. Various designs of tubes are available to meet physician preference. The PC1036 coating has been shown to be resistant to staphylococcal biofilm formation and pseudomonal biofilm formation.

Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent episodes of acute otitis media despite conventional medical treatment . A record of persistent high negative middle ear pressure associated with one or . more of the following system: 1. Conductive hearing loss that is symptomatic 2. Persistent or recurrent otalgia 3. Persistent or recurrent vertigo, tinnitus, or both . Atelectasis resultant from retraction pocket of the tympanic membrane or . eustachian tube dysfunction.

The Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes are manufactured from Blue (PTFE) Fluoroplastic and are supplied sterile. Various designs are available.

An ossicular replacement prosthesis is a device intended to the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications for use include: Chronic middle ear disease, Otosclerosis, Congenital fixation of the stapes, Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and surgically correctible injury to the middle ear from trauma.

The family of Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses consists of: Grace Medical ALTO (Adjustable Length Total Ossicular) Prostheses Grace Medical ALPO (Adjustable Length Partial Ossicular) Prostheses Grace Medical FLTO (Fixed Length Total Ossicular) Prostheses Grace Medical FLPO (Fixed Length Partial Ossicular) Prostheses Silverstein ALTO (Adjustable Length Partial Ossicular) Prostheses with Footplate Tack Grace Medical Frisbee Myringopexy (Fixed Length Partial Ossicular) Prostheses. The Grace Medical Adjustable Length and Fixed Length Partial & Total Ossicular Replacement Prostheses are manufactured from the same or similar materials as the predicate devices. The Grace Medical Adjustable-Length PORP's and TORP's contain a medical grade silicone sleeve fixed to the titanium shaft which allows for adjustment to length by the user. Various designs of Grace Medical Adjustable Length Partial & Total Ossicular Replacement Prostheses are available to meet physician preference.

A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include: (a) Chronic middle ear disease, (b) Otosclerosis, (c) Congenital fixation of the stapes, (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and (e) Surgically correctible injury to the middle ear from trauma.

The Grace Medical Stapes Prostheses are manufactured from the same or similar materials as the predicate devices. Various designs of Stapes Prostheses are available to meet physician preference. Materials include Titanium, Fluoroplastic, Stainless Steel, Platinum, Tantalum, Silicone, and Nitinol. Shaft diameters range from 0.3 to 0.8 mm and functional lengths range from 3.0 to 6.5 mm. The devices are supplied sterile.

Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications include: Chronic middle ear disease, Otosclerosis, Congenital fixation of the stapes, Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, Surgically correctible injury to the middle ear from trauma

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