Earlens Sitting Hybrid Impressin Prcedure System 1. Intrductin... 2 2. Earlens Hybrid Impressin Prcedure and System Descriptin... 2 3. Precautins... 2 4. Indicatin fr Use... 3 5. Cntraindicatins... 3 6. Clinical Study Results... 3 7. Operating Instructins... 4 8. Graphic Symbls Cntained in Device Labeling... 8 1
1. Intrductin CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. Rx ONLY 2. Earlens Hybrid Impressin Prcedure and System Descriptin Instruments and materials: Impressin Return Bx w/ Label Tpical Light Mineral Oil (OIL02) Impressin Dispensers (IDG01 nly) Medial Impressin Material Cartridge (blue, lw viscsity material) Medial Impressin Mixing Tip Lateral Impressin Material Cartridge (pink, high viscsity material) Lateral Impressin Mixing Tip Tray (small dispsable dish fr hlding mineral il) Additinal standard tlgic ffice supplies are required, which may include: Ear Specula: multiple sizes Wax curette Triangular tipped metal cttn applicatr Small suctin tips (recmmend 5 Gauge, 3 Gauge, and 20 Gauge) Thin curved elevatr Spatula Gauze pads: 4x4 Sft Cttn EPA registered hspital disinfectant wipes 3. Precautins Befre using the Earlens Sitting Hybrid Impressin Prcedure and System, read and make sure yu understand each f the fllwing safety precautins. 2
It is imprtant fr the physician t use the specified impressin materials in the prper sequence when perfrming this deep impressin, and the instructins are fllwed. N substitutins fr materials in the impressin system are allwed. The impressin prcedure shuld be perfrmed by a physician with relevant experience, such as an ENT r Otlgist. When using any instruments in the ear canal and particularly when the mixing tip is submerged, be careful t avid damaging the ear canal r tympanic membrane. D nt perfrm the impressin prcedure if the Impressin Dispenser r any ther cmpnent appears t be damaged r expired. D nt use the lateral impressin material in the medial sectin f the ear canal. This material is nt indicated fr use in deep canal impressins and shuld be used exclusively in the lateral sectin f the ear. 4. Indicatin fr Use The Earlens Sitting Hybrid Impressin Prcedure is intended fr use in individuals 18 years and lder t generate an ear canal impressin. 5. Cntraindicatins Perfrated tympanic membrane Otitis externa Visible hematma, bleeding, r effusin Hypersensitivity t cntact resulting in bleeding r hematma is at the discretin f the physician Bny exstsis, atresia, r excessively restrictive anatmy that wuld cause difficulty remving the impressin material r inability t view the tympanic membrane is at the discretin f the physician 6. Clinical Study Results 6.1. Study Overview Earlens cnducted an impressin study t cllect ear impressins frm many different ear canal anatmies and t gain experience with the deep canal impressin prcedure itself. 6.2 Study Demgraphics A ttal f 78 subjects had bilateral ear canal impressins taken (37 female, 41 male). The ttal number f ears that had impressins taken was 154 (2 subjects had unilateral impressins). Subject age ranged frm 32 t 82 years with an average f 66.1 years. The subjects were seen acrss three clinical sites. 6.3 Outcmes Number f Impressins A ttal f 200 ear impressins were taken n 154 ears (78 subjects). Furteen subjects (18%) required mre than ne clinic visit t btain adequate ear impressins. Multiple impressins were required n sme subject ears due t the presence f vids in the impressin f anatmical areas that are critical t the custm-build f the Tympanic Lens. The average number f impressins per subject was 2.6, r 1.3 per ear. Thirty-eight percent f subjects required three r mre impressins; 17% required fur r mre impressins. Cmfrt During Prcedure Based n a subject survey, a ttal f 84% f impressins were rated as either n discmfrt r mild discmfrt. 3
Ear Canal Status While 80% f the study ears were bserved t be nrmal (unremarkable tscpic inspectin) after the impressin prcedure, the remaining ears were reprted with minr skin cntact findings. The mst cmmn bservatin was a micr-hematma (16%) while petechia (1%), ecchymsis (2%) and abrasin (1%) was reprted less frequently. All tlgic findings reslved withut treatment and withut sequelae. Micr-hematmae and ecchymses can take 2-4 weeks t reslve. Abrasin and petechia, depending n extent and lcatin, can be a mre minr finding and may r may nt require delay f subsequent tlgic prcedures, including Tympanic Lens placement. 7. Operating Instructins 1. Prvide an verview t the patient abut the impressin prcess and what t expect, including: The ear will be inspected fr any cntraindicatins. The ear will be cleaned, any wax r skin debris present will be remved, and the ear canal will be lubricated with mineral il. Frm the cleaning prcedure there may be sensatins such as a cugh reflex, tickle, r general discmfrt. The ear canal and cnchal bwl will be filled with impressin material. The patient shuld remain still and try and hld their muth clsed in a resting psitin withut clenching teeth. The patient shuld avid talking while the impressin material is curing in the ear. The patient may feel a sensatin f fullness when the impressin material is being applied t the ear canal. The patient will be in bth the supine and seated psitin during the prcedure. In a supine psitin the medial blue material is inserted int the medial ear canal. After eight minutes, the medial impressin material will set-up and cure. During this time, the sensatin f hearing may be diminished due t the presence f the impressin material in the ear canal. After the medial impressin, the patient will be asked t mve t a seated psitin and lateral (pink) impressin material will be inserted int the ear canal. This material will cure ver three minutes. It is imprtant that the patient desn t talk r therwise mve their jaw during this curing time. The impressin is then remved. This may cause a sensatin f pressure r discmfrt. There is a pssibility f discmfrt, bruising, abrasin and/r minr bleeding f the ear canal during this prcedure. 2. Perfrm an tlgic exam and inspect the external auditry canal and the tympanic membrane fr the presence f any cntraindicatins. D nt prceed with the impressin prcedure if any f the cntraindicatins are present. 3. Clean cerumen and epithelial debris frm the ear canal, anterir sulcus, and tympanic membrane. Use a cttn wisp and the prvided mineral il. D nt use any water based cleaning fluids. D nt prceed with the impressin if bleeding r if a hematma ccurs as a result f the cleaning prcess. 4. Wipe ut the ear canal, TM and anterir sulcus with a clean cttn wisp t remve any excess il. Repeat with a new cttn wisp until it cmes ut dry. Avid any pling f mineral il, which may cause defects in the quality f the impressin. 5. Prepare the Impressin Dispensers, Impressin Material Cartridges, and Mixing Tips fr dispensing: Test the actuatin f bth Impressin Dispensers, ensuring that the handles smthly ratchet the pistn frward. D nt use an Impressin Dispenser if it appears t be damaged. Lad the Medial Impressin Material Cartridge int ne Impressin Dispenser. The lwer viscsity, blue, medial impressin material is intended t be put deep in the ear canal and in cntact with the tympanic membrane. Lad the Lateral Impressin Material Cartridge int the ther Impressin Dispenser. The higher viscsity pink, lateral impressin material is intended t be depsited lateral t the medial impressin 4
in the uter ear canal. IMPORTANT: D nt use the lateral impressin material in the medial sectin f the ear canal. This material is nt indicated fr use in deep canal impressins and shuld be used exclusively in the lateral sectin f the ear and is NOT intended t be in direct cntact with the tympanic membrane. Remve the caps frm the impressin cartridges. Prir t attaching the Mixing Tip, prime the Medial Impressin Cartridge by dispensing a small amunt f medial impressin material nt a piece f gauze r an equivalent, then wiping any excess material ff f the end f the cartridge. Cnfirm that bth materials (blue and white) are advancing equally frm the tip. IMPORTANT: Ensure there is nt mixing f the tw materials (blue and white) between the utlets f the cartridge after wiping. Prir t attaching the Mixing Tip, prime the Lateral Impressin Cartridge by dispensing a small amunt f medial impressin material nt a piece f gauze r an equivalent, then wiping any excess material ff f the end f the cartridge. IMPORTANT: Ensure there is nt mixing f the tw materials (pink and white) between the utlets f the cartridge after wiping. Attach the single use Mixing Tips t the respective impressin material cartridges. Orient the curved tip n the Medial Impressin Mixing Tip fr the right r left ear. 6. First psitin the patient in the supine psitin. Then psitin the patient s head fr making the impressin, being sure that there is an adequate view f the tympanic membrane, and dispense the medial (blue) impressin material int the ear: With the speculum in place, place the distal end f the mixing tip between the umb and the inferir anterir annular area. Start a timer. Slwly dispense the impressin material int the anterir sulcus and nt the tympanic membrane. Nte: It is imprtant nt t mve the tip f the dispenser until the tympanic membrane is fully cvered keeping the Mixing Tip submerged. T rapid f a flw may trap air in the anterir inferir sulcus and in the pars flaccida area, which will yield an incmplete impressin. As a guide, allw apprximately 10-15 secnds t fully cver the tympanic membrane, dispensing material at a slw and steady pace. Once the tympanic membrane and pars flaccida are cvered with the impressin material, slwly withdraw the tip laterally, keeping the tip slightly submerged and prceed t mre rapidly fill the external auditry canal up t a level slightly medial f smth skin/glandular skin transitin n the anterir / superir aspect f the canal. The medial impressin material shuld nt be filled beynd the smth skin/glandular transitin. Stp dispensing the medial impressin material. Allw the medial impressin material t cure fr a minimum f eight minutes after the cmpletin f the medial impressin. The patient shuld remain still and hld the muth clsed in a resting psitin withut clenching teeth. The patient shuld avid talking while the impressin material is curing in the ear. 7. Repsitin the subject t a sitting psitin with head and back as vertical as pssible and begin the lateral impressin. The patient shuld remain still, with head facing frward, and hld the muth clsed in a resting psitin withut clenching teeth. Purge the air frm the Lateral Impressin Material Cartridge by squeezing the handle until a small amunt f the impressin material exits the end f the cartridge. Wipe the tip clean. Attach the Mixing Tip. Psitin the Lateral Mixing Tip int the canal against the existing medial impressin material. The 5
distal end f the Lateral Mixing Tip shuld be directed twards the superir aspect f the existing medial impressin material (blue) that was previusly dispensed int the ear canal. Start a timer fr the 3 minute duratin While dispensing the lateral impressin material, ensure the distal end f the Mixing Tip remains submerged in the lateral impressin material as the remaining aspects f the canal are filled. Slwly withdraw the tip laterally as the canal is filled, keeping the tip submerged, while maintaining a cnsistent dispensing speed. Once yu have cmpletely filled the canal, advance the material in a clckwise directin fr the right ear and cunterclckwise directin fr the left, filling the cncha bwl first. Fill the canal and cncha bwl with the Lateral Impressin Material (pink) t the level f the scapha, cvering the tragus and filling the cncha cymba. Optinally, create a pile f the impressin material that prtrudes laterally frm the cncha bwl fr ease f impressin remval. Allw the lateral impressin material t cure fr a minimum f three minutes in the sitting psitin. The patient shuld remain still, with head facing frward, and try and hld the muth clsed in a resting psitin withut clenching teeth. The patient shuld avid talking while the impressin material is curing in the ear. 8. Reset the Impressin Dispensers by depressing the lever n the back f the pistn and pulling prximally, detach the Impressin Material Cartridge and Mixing Tip frm each Impressin Dispenser. Discard the single-use Mixing Tips, and discard the Impressin Material Cartridges, if desired. It is acceptable t save the impressin material cartridges fr use in anther impressin if there is adequate unused material left. Nte: The Impressin Dispenser has a useful life f 300 patients. 9. With the subject in an upright sitting psitin remve the fully cured impressin. Lsen the impressin frm the cnchal skin and external auditry canal and break the seal between the impressin material and the ear canal wall. Carefully remve the cured impressin material frm the ear. Ask the patient t pen and clse their jaw as if they are trying t pp their ears While grasping the impressin and pulling the pinna psterirly t straighten the canal, slwly rtate the impressin tward the patient s nse (anterir directin) while gently increasing the amunt f pull frce applied. Gentle twisting frces may be applied as the impressin is slwly remved frm the ear canal. Ask the patient t indicate whether they experience a feeling f a pressure drp r an increase in hearing. This is a sign that an air leak path dwn t the tympanic membrane has been frmed. 10. Inspect the ear canal and tympanic membrane. 11. Inspect the impressin t see if it is cmplete and acceptable r requires a repeat attempt. Flaws that may require a repeat attempt include the fllwing (see Figures 1, 2, 3): Inclusin f cerumen r epithelial plaques in the umb and anterir sulcus areas. Vids, flaws and bubbles in the area f the umb r anterir sulcus areas indicating an incmplete impressin in the tympanic membrane regin. Vids, flaws, and bubbles at the transitin r junctin between the medial and lateral impressin material culd indicate an incmplete impressin. Ensure the transitin pint is nt past the smth skin/glandular skin transitin. Vids, flaws, and bubbles indicating an incmplete impressin in the ear canal and cnchal bwl regin. Small bubbles and vids are acceptable in the ear canal and cnchal bwl regins. 12. If the impressin is unacceptable, repeat the prcedure a secnd time, beginning with Step 4. D nt repeat the prcedure if any f the cntraindicatins have develped. D nt exceed tw attempts per ear per day. 13. Repeat all steps fr the ppsite ear (if necessary). 14. Once all impressins fr a single patient are cmpleted, and if impressin material is ging t be used 6
n a subsequent patient, replace the clean cap n the cartridge. Wipe dwn the dispenser and impressin material cartridge (if re-use is planned) with an EPA registered hspital disinfecting wipe t prevent any pssible crss cntaminatin. Dispse f all single-use items. 15. Prepare and send the impressin(s) t Earlens by placing all impressins taken in the supplied Impressin Return Bx and labeling the cntainer with patient identificatin. Figure 1: Medial Sulcus Impressin Examples an ideal medial impressin features a cmplete sulcus which is needed t prepare an adequate cntact platfrm fr the Lens. Figure 2: Medial & Lateral Junctin Impressin Examples an ideal junctin features a smth transitin between the medial and lateral materials with n vids. Figure 3: Lateral Impressin Examples Figure 3: Lateral Impressin Examples an ideal lateral impressin has n flds r vids and is smth. 7
8. Graphic Symbls Cntained in Device Labeling Symbl Descriptin Reference Symbl Descriptin Reference Cnsult instructins fr use 5.4.3 Temperature limit 5.3.7 Use-by date 5.1.4 Cautin 5.4.4 Batch cde 5.1.5 Catalg number 5.1.6 CE cnfrmity marking MDD 93/42/EEC, Annex XII Cautin: Federal law restricts this device t sale by r n the rder f a (licensed healthcare practitiner) FDA Final Rule 81 FR 38911 Humidity limitatin 5.3.8 Manufactured by (Ref. 5.1.1): Earlens Crpratin. 4045A Campbell Ave. Menl Park, CA 94025 Eurpean Authrized Representative (Ref. 5.1.2): Medimark Eurpe SARL 11, Rue Emile Zla, B.P. 2332 F-38033 Grenble Cedex 2 France 2019 Earlens Crp. All rights reserved. 8