9. Bone-Anchored Hearing Aids_stu.pptx
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Types of Devices Ponto Bone-Anchored Hearing System Baha Bone Conduction Sophono Bone-Anchored System Hearing System (Oticon Medical) (Cochlear) (Bone Conduction Hearing) History Titanium osseointegrated im...
Types of Devices Ponto Bone-Anchored Hearing System Baha Bone Conduction Sophono Bone-Anchored System Hearing System (Oticon Medical) (Cochlear) (Bone Conduction Hearing) History Titanium osseointegrated implants Dental implants 1965 BAHA adult 1977 BAHA pediatric 1989FDA approved > 5yo Bone reduced discomfort Anchored Devices improved sound quality Implant material Implant design Surface quality Bone status Surgical technique Loading conditions Osseointegration Bone Anchored Device Design Cochlear Bone Anchored System Cochlear Oticon Medical Baha System (Cochlear) Size (Length × Width × 26 × 19 × 12 mm 26 × 19 × 12 mm 36 × 22 × 13 mm 30 × 21 × 12 mm Thickness) Weight 11.5 g 9.8 g 17 g 11.6 g Fitting range Up to 55 dB SNHL Up to 45 dB SNHL Up to 55 dB SNHL Up to 45 dB SNHL Average MPO 113 dB 106 dB 114 dB Frequency range 200–9850 Hz 250–7000 Hz 250–7000 Hz 250–6700 Hz Visual indicator ✓ ✓ (LED) Dust and water IP68 IP63 IP63 resistance SmartSound® iQ scene classifier & ✓ ✓ ✓ noise reduction Direct streaming to ✓ (+ Android) ✓ ✓ Apple™ devices NEW Baha Smart Baha 5 Smart App Baha 5 Smart App Baha Control App Smart App App for iOS & Android for iOS & Android (no longer available) for iOS & Android Baha System (Cochlear) Cochlear Corp. Oticon Medical Ponto Size (Length × Width × 34 x 21 x 14 mm 31 x 21 x 15 mm 34 x 21 x 11 mm 26 x 19 x 11 mm 26 x 19 x 11 mm Thickness) Weight 17 g 20 g 14 g 13.2 g 13.2 g Fitting range Up to 65 dB HL Up to 65 dB HL Up to 45 dB HL Up to 45 dB HL Up to 45 dB HL Average MPO 113 dB 106 dB 114 dB Frequency range 260–9500 Hz 200–9500 Hz 200–9500 Hz 200–9500 Hz 200–9500 Hz Visual indicator (LED) ✓ ✓ ✓ Dust and water IP57 IP57 IP57 IP57 IP57 resistance BrainHearing™ ✓ ✓ ✓ ✓ ✓ technology OpenSound™ ✓ ✓ Optimizer Made for iPhone ✓ ✓ ✓ Oticon ON App Oticon ON App Oticon ON App Oticon Medical Oticon Medical Remote Control App or Remote or Remote or Remote Streamer Streamer Control 3.0 Control 3.0 Control 3.0 Via Oticon 2.4 GHz Via Oticon 2.4 GHz 2.4 GHz Stereo streaming Medical Bluetooth Low Medical Bluetooth Low Bluetooth Low Ponto Connectivity 1.Skull bone 2.Skin and subcutaneous tissue 3.Implanted titanium fixture 4.Titanium abutment Rationale Intended Use Conductive & Mixed Losses Sound processor sends sound directly to cochlea via bone conduction Signal bypasses conductive element: less amplification required compared to conventional HAs Unilateral Profound Sensorineural Hearing Loss (Single Sided Deafness, SSD) Sound processor acts as a CROS device Placed on patient’s deaf side to pick up sound that is transferred to functioning contra cochlea Other indications Skin allergies or external otitis Ear canal stenosis Indications Unilateral or bilateral conductive hearing loss Congenital aural atresia/microtia Chronic suppurative otitis media Chronic otitis externa Middle ear dysfunction/ossicular disease Unilateral or bilateral mixed hearing loss Unilateral sensorineural hearing loss Failure with conventional hearing aids Learning or behavioral difficulties with BTE hearing aids Otitis externa OID benefits over BC & AC HAs Sound quality Improved speech perception in noisy and quiet environment Sound localization? Quality of life, comfort Candidacy: Conductive Losses Size of air-bone gap Air-bone gap >30 dB PTA (.5, 1, 2, 4k) Is Air-Bone Gap >30 dB? ABG = (40+40+40+35)/4=39dB 39 dB > 30 dB Average BC threshold WNL in conductive hearing loss Candidacy: Mixed Losses Size of air-bone gap Air-bone gap >30 dB PTA Size of sensorineural element (mixed loss) PTA BC Θ for indicated ear should be ≤65 dB HL Ensures sound processor can provide sufficient amplification for SN component with MHL Is Air-Bone Gap >30 dB? ABG = (30+35+45+40) / 4 = 38 dB 38 dB > 30 dB Is average BC threshold ≤ 65 dB HL? Avg BC = (20+25+30+35)/4=28dB HL 28 dB HL ≤ 55 dB HL Treatment Benefits Advantages compared to conventional air conduction HAs: Sound signal bypasses conductive component of the hearing loss Ear canal remains open Reduced amplification needed decreases the risk of feedback Advantages compared to middle ear surgery: Bone anchored sound processor can be evaluated before surgery Surgical procedure is simple & reversible Advantages compared to conventional bone conductors: Patient comfort is improved Sound quality is better Implanted sound processor is more discreet Candidacy: Single Sided Deafness (SSD) Degree of hearing loss in the good ear The PTA (.5, 1, 2, 3k) air conduction threshold of the hearing ear should be ≤ 20 dB HL AC Candidates for AC CROS HA, but for some reason cannot use one Is average AC threshold in the good ear ≤ 20 dB HL? Avg AC=(10+10+15+20)/4=14dB HL 14 dB HL ≤ 20 dB HL Treatment Benefits Single-sided deafness patients Reduced head shadow effect Improved speech intelligibility in noise Advantages compared to AC CROS HA: Ear canals remain completely open No cables needed for transmitting sound to hearing cochlea Only 1 device needed, rather than 2 units for AC CROS system Evaluation FDA approved for age 5 and above Audiogram Trial of soft band bone conduction hearing aid Hol et al 2005 To demonstrate and evaluate benefits, sound processors can be connected to: Headband Pre-operative Trial Bilateral Fittings For candidates with bilateral conductive or mixed HL Result in improved sound localization and speech recognition in noise Difference between left and right BC Θ’s should be: < 10 dB on average (0.5, 1, 2, 4 kHz) < 15 dB at individual frequencies If BC Θ’s asymmetric, bilateral OIDs won’t provide localization and improved speech in noise Patients may still benefit from reduction of head shadow effect Side Selection If fitting single sound processor on patient with bilateral HL: Select side with best BC Θ’s If can’t determine from audiogram, trial should include placing the processor on each side to help patient decide which side is the best Practical considerations Manual dexterity Phone ear / writing ear Driving Cautions & Contraindications Poor hygiene Insufficient bone depth and bone quality Children must have sufficient bone volume and bone quality Child should have a skull bone at least 2.5 mm thick In US & Canada, placement of a bone anchored device is contraindicated in children < 5 years Any skin status or condition resulting in an expected reduced healing capacity or increased risk of skin reactions Surgical Technique Considerations for surgery One versus two stage surgery Size of fixtures Dura/sigmoid sinus exposure Surgical Consideration Two separate procedures or one combined procedure? 1st stage - place the fixture 2nd stage - place abutment One vs Two Stages Skull thickness Craniofacial anomalies Younger children Distance from care Age/maturity speech and technical language limitations Airway Choosing Abutment Length Natural skin Abutment thickness length 0.5-3 mm 6 mm 3-6 mm 9 mm 6-10 mm 12 mm Oticon Medical Cochlear Corp Choose & Mark Site One-stage Two-stage Raise Flap Taking Graft Cochlear Corp Dermatome Cochlear Corp Raise Periosteum Cochlear Corp Drilling Bone Cochlear Corp Countersinking Cochlear Corp Inserting Fixtures Cochlear Corp Place Cover Screw Two-stage Surgical Considerations Bone Single Two Thickness Stage Stage 4 mm Soft-Tissue Preparation Cochlear Corp Close and Suture Cochlear Corp Dressing the Abutment Cochlear Corp Minimally-Invasive Surgical Options MIPS MONO Single-stage procedure Single-stage procedure Minimally invasive Small incision Minimally invasive Local anesthetic Small incision Candidates: Local anesthetic Adults with normal bone quality One-drill step Bone thickness above 3 mm Candidates: No surgical complications expected Children (12+ yrs) with normal bone quality Adults with normal anatomy Bone thickness above 4 mm Bone thickness of at least 5 mm No surgical complications expected No surgical complications expected 1 week post-op 3 weeks post-op MIPS Procedure MONO procedure MONO Surgery Surgical Complications Extrusion/Failure of osseointegration (3-10%) Skin infection/reaction (7.5%) Skin overgrowth (5-20%) Operative complications ( 5 years of age 9 months for children < 4 years of age 2 stage procedure Apply device 6-8 weeks later Follow up/Maintenance Need regular follow-up initially 1, 3, 6 months, then every 6 months Skin care and abutment hygiene critical Personal Hygiene Cochlear Corp Audiometric Results 40 patients Lustig et al., Otology and Neurotology, 2001 Ongoing Complications Extrusion or loosening of the titanium implant 3% in adults, 5-10% in children Skin problems (20%) Inflammation/infection Granulation Keloid formation Skin growth over abutment (7%) Improvement in design Wider diameter Smaller sized thread at the implant neck Roughened surface on intraosseous part Varied lengths in abutments Ponto-- angled abutment (10°) Transcutaneous Implant: Sophono™ Alpha 2 Bone Conduction Hearing System Indication: BC better or equal to 45dB Surgically implanted internal plate with two magnets As good as a bone conduction hearing aid 3-Tesla MRI compatible Mulla et al 2012 Implanted Bone Conduction vibrator Direct Drive Direct Contact (Percutaneous) Vibrator Devices Vibration in processor Vibrator held by Softband/Headba Skin Drive nd No Direct (Transcutaneous Contact Vibrator / Indirect) Vibrator held by implanted magnet Bone Anchored Solutions Transcutaneous vs Percutaneous Cochlear ™ Vistafix® System Fitting and Verification of Bone Anchored Devices Osseointegrated Device Advantages Drainage Allows for natural ear canal resonance SPLogram Method that allows clinician to define Dynamic Range (DR) of hearing in some common metric In the case of AC HAs, this method involves steps that allow for the definition of threshold and loudness discomfort levels in dB SPL Once DR of hearing is defined, prescriptive algorithms can be used to map targets for aided speech at multiple inputs into that individual DR of hearing SPLogram Includes thresholds, targets, and hearing aid verification curves FLogram Mixed/Conductive vs Single Sided Deafness Mixed/Conductive: Flat bone conduction frequency response Single Sided Deafness (SSD): Decrease in gain in the low frequencies Increase in gain in the mid frequencies Even more increase in gain in the high frequencies Bilateral Fittings Software will account for binaural summation Checking box will decrease the overall gain BC thresholds within 10 dB of each other between ears If difference >15 dB bilateral devices may not be appropriate Unilateral fitting of asymmetrical hearing loss, side with better BC Θ’s typically implanted Symmetrical BC thresholds have best outcomes If bilateral conductive & cannot complete masked BC due to masking dilemma, complete Weber test Feedback Feedback from bone conduction devices typically mechanical Feedback from conventional hearing aids typically acoustical The Pediatric Alternative Most of the children fit with this type of device use a softband Where can the device be worn on the head? Unilateral vs Bilateral Fitting Considerations Softband Placement P ORN POPCORN OPCORN POPCOR N POPC Rady Children’s Hospital – San Diego Bad Placement On the back of the head Sitting on a bed of hair The Bad and the Good Rady Children’s Hospital – San Diego Good Placement Coupler is sitting on skin Coupler just above pinna where hair meets skin Cochlear Corp. Rady Children’s Hospital – San Diego Sound Arc: Always Good Placement BC Measurement for Softband placement gain prescription High temporal bone Child 4 yrs BC in-situ Mastoid(s) If auditory thresholds not available Conductive Enter 0 dB BC HL Mixed Enter L & R estimated Θ’s Enter 0 dB BC HL in “good SSD ear” Pediatric Fitting Guide Before child comes to clinic If child can do BC In-situ Enter BC-thresholds in NOAH measurement With child in clinic Open software, put battery in the Click BC In-situ sound processor, Open software, put a Audiometry Click Selection, select battery in & connect Conduct BC In-situ HL (CHL or SSD) device measurement Connection (Abutment or Softband) Click Detect & continue Evaluate & if necessary Click Fitting adjust Click Fitting Choose Directionality re: device Mute device Click End Fitting placement & age of child Place device on child or Save, Program, & Exit Click End Fitting: on abutment Buttons & Beeps/Indicators Un-mute device Verify processor functionality is set based on needs of child Click Feedback Manager Save, Program, & Exit Click Start to measure individual feedback limit Abutment versus Softband Abutment: Percutaneous direct bone conduction Attract: Transcutaneous Softband: Indirect through skin Cochlear Corp. Position Compensation Defined as: Software adjustment necessary because of location of the microphone Turn “on” when device is worn behind the ear Either abutment or softband Turn “off” if device position is variable Avoiding hotspots with softband use Additional Programming Options Do you need a separate program for FM? Indicator light? Disable VC or program button? Tamper proof battery door? VERIFICATION How to Verify Benefit Cannot use Verifit Skull simulator Aided (soundfield) gain Speech testing Localization Patient/parent questionnaire Clinical Workflow Prescribe listening Use patient’s own levels Fit to targets using device to remeasure Shaped across freqs speech inputs Θ‘s Compressed across Measure output on input levels skull simulator Assess direct BC Limited to device- FLogram specific MFO Verify device hearing via output abutment Audioscan Verifit Skull Simulator Can directly compare the force- level targets generated by DSL- BCD v1.1 to the actual output of the devices Aided (Soundfield) Gain Testing Use pulsed, narrow band noise Some devices consider soft sounds to be noise Expansion in device will turn down the gain for these sounds Unilateral HL: plug good ear, test aided gain with device turned on & off Concerns regarding validity Snapp HA, Morgenstein, KE, Kuzbyt B. (2019). Speech perception outcomes in transcutaneous versus percutaneous bone conduction stimulation in individuals with single-sided deafness. Otology & Neurotology 40(8): 1068-1075. doi: 10.1097/MAO.0000000000002362 Speech Testing Ling sounds Aided speech reception/detection threshold Speech testing Age appropriate word lists Speech in noise tests: AzBio, BKB-SIN, Quick-SIN CNC / BKB-SIN Snapp HA, Morgenstein, KE, Kuzbyt B. (2019). Speech perception outcomes in transcutaneous versus percutaneous bone conduction stimulation in individuals with single-sided deafness. Otology & Neurotology 40(8): 1068-1075. doi: 10.1097/MAO.0000000000002362 SPIN Newman CW, Sandridge SA, Wodzisz LM. (2008). Longitudinal benefit from and satisfaction with the Baha system for patients with acquired unilateral sensorineural hearing loss. Otology & Neurotology 29(8): 1123-1131. doi: Saliba I, Nader ME, El Fata F, Leroux T. (2011). Bone anchored hearing aid in single sided deafness: Outcome in right-handed patients. Auris Nasus Larynx. 38(5): 570–576. Dillon M, et al. (2016). Cochlear Implantation in Cases of Single-Sided Deafness. American Auditory Society annual meetng. Functional Measures: Localization No improvement in localization with use of an OID Some reports of improvement in speech recognition when speech in front & noise behind compared with both speech & noise from front The minimum audible angle decreased from 57° in the best monaural condition to 13° in the bilateral condition Newman C. et al. (2008). Otology & Neurotology, 29(8): 112 1131. Dun CA, et al. (2013). Ear & Hearing, 34(6): 806-808. Functional Measures: APHAB Newman CW, Sandridge SA, Wodzisz LM. (2008). Longitudinal benefit from and satisfaction with the Baha system for patients with acquired unilateral sensorineural hearing loss. Otology & Neurotology 29(8): 1123-1131. doi: Functional Measures: HHIA & SSDQ QoL Newman CW, Sandridge SA, Wodzisz LM. (2008). Longitudinal benefit from and satisfaction with the Baha system for patients with acquired unilateral sensorineural hearing loss. Otology & Neurotology 29(8): 1123-1131. doi: 10.1097/MAO.0b013e31817dad20 Functional Measures: SSDQ QoL Newman et al., (2008) Non-Surgical Options Baha Softband & SoundArc Ponto SoftBand Contact Mini & Forte Contact Mini vs ADHEAR Contact Forte vs ADHEAR https://www.bhm-tech.at/media/65/0d/e0/1666253121/contact_mini_vs_adhe ar.pdf https://www.bhm-tech.at/media/f2/f4/f3/1666252994/22_03_Vergleich_conta ctforte_adhear_A4_web.pdf Bruckhoff Hannover hearing aids: as spectacle hearing aid as headband as headset C.A.I. Conchae Anchored Instrument Bone Conduction Eyeglasses Bruckhoff Hannover GmbH Bone Conduction Eyeglasses Bruckhoff Hannover GmbH