Yttrande från Metodrådet HTA, 2014:14

Avd Stöd för evidensbaserad medicin
Metodrådet SLL-Gotland
Claes Lennmarken
Elisabeth Persson
DATUM
2014-10-24
Yttrande från Metodrådet HTA, 2014:14
Aktiva mellanöreimplantat-AMEI
Ställd fråga: Förbättras hörsel och livskvalitet med aktiva mellanöreimplantat (active middle
ear implant, AMEI, MEI, AHI) jämfört med användning av konventionell extern hörapparat
hos patienter med sensorineural hörselnedsättning eller ledningshinder?
Frågeställare: Mats Holmström, Professor, Öron-näsa-halskliniken, Karolinska
Universitetssjukhuset.
Kort sammanställning av kunskapsläget:
En begränsad litteratursökning har genomförts. Samtliga publikationer var
observationsstudier med små patientmaterial.
Två systematiska översiktsartiklar identifierades; El-Hakim H et al. Från 2011 (1) och
Verhaert N et al. från 2013 (2) samt ett policydokument från National Health Service (NHS) i
Storbritannien från 2013 (3) Dessa publikationer tillsammans med en svensk kostnads-nytto
analys (4) utgjorde de huvudsakliga underlagen för detta yttrande.
I en HTA rapport ”Middle Ear Implants for the Treatment of Hearing Loss” från University of
Albertha, Edmonton, Kanada (1) baserad på 135 artiklar konkluderades: “Although the
technology has been in use for over 10 years, good quality evidence on MEI is still lacking. In
patients medically able to wear conventional hearing aids, the evidence indicates that MEI
offers a similar improvement in functional gain to that achieved with conventional hearing
aids, but may offer greater improvement with respect to perception of speech in noise and
sound quality. In the small group of patients who are medically unable to use conventional
hearing aids, MEI appears to offer a viable treatment option.”
Verhaert et al. (2) konkluderade: “The current systematic review shows that AHI and their
different coupling strategies in the treatment of MHL were beneficial in terms of speech in
quiet, PROM* and safety regarding residual hearing. Overall, the level of evidence and the
quality of the included studies were judged to be moderate to low. More comprehensive data
on coupling to the inner ear and the comparison with conventional hearing aids or
alternatives for speech in noise is mandatory. Long-term follow-up data are also needed.”
I NHS Commissioning Policy Statement: “Active Middle Ear Implants” från april 2013 (3)
sammanfattades evidensen efter genomgång av 32 referenser:“ In summary the review found
that there were major limitations in the evidence available. There was a lack of high-level
evidence on the relative effectiveness and safety of the middle ear implant compared with
other recognized treatments. The evidence available consisted of comparative studies and
case series that were all subject to bias and confounding. Findings must be interpreted
cautiously. Most studies are of the Vibrant Soundbridge device.”
Stockholms läns landsting
Box 6909
102 39 Stockholm
Telefon: 08-123 132 00
Fax: 08-123 131 07
E-post: [email protected]
Säte: Stockholm
Org.nr: 232100-0016
www.sll.se
Besök oss: Magnus Ladulåsgata 63A. Kommunikationer: T-bana Medborgarplatsen
http://www.vardgivarguiden.se/utbildningutveckling/Vardutveckling/HTA/HTA-yttrande/HTA-yttrande/Aktivamellanorenimplantat-AMEI/
2 (2)
I dokumentet görs bedömningen:“Active middle ear implants are not routinely commissioned
except under circumstances when no other alternative treatment is available.”
Kostnads-nyttoanalysen av Edfeldt et al. 2014 (4) visade att kostnad per kvalitetsjusterat
levnadsår (QALY) var låg (7260-12503 €/QALY enligt 2012 års valutakurs).
Bedömning:
Evidensläget har bedömts som begränsat. Indikationer finns på att patienter som inte kan
använda konventionell hörapparat kan ha nytta av AMEI. Kostnadseffektiviteten är hög för
denna patientgrupp.
Konsulterade experter: Bo Ahlner, med.dr, överläkare, Enheten för vuxenrehabilitering,
Linda Rietz, specialistläkare, Hörsel- och balanskliniken, Erica Billermark, Leg. audionom,
Sektionen för Cochleaimplantat, Henrik Smeds, bitr. överläkare, Öron-näsa-halskliniken,
samtliga Karolinska Universitetssjukhuset.
Christina Lindberg, informationsspecialist, Jonas Hermansson, statistik/hälsoekonomi, båda
från Metodrådet SLL-Gotland.
Ovan refererade artiklar:
1. El-Hakim et al. STE-rapport (HTA). Middle ear implants for the treatment of hearing
loss. Health Technology Assessment Database [Internet]. 2011.
http://www.health.alberta.ca/documents/AHTDP-MEI-UofA-STE.pdf
2. Verhaert N et al. Acoustic hearing implants for mixed hearing lss: a systemic review.
Otology&Neurotology 34: 1201-1209, 2013.
3. NHS Commissioning Board. Clinical commissioning policy statement: active middle
ear implants 2013. http://www.england.nhs.uk/wp-content/uploads/2013/04/d09-psa.pdf.
4. Edfeldt L et al. Evaluation of cost-utility in middle ear implantation in the ’Nordic
School’: a multicenter study in Sweden and Norway. Acta Otolaryngol. 2014 Jan; 134
(1):19-25.
För Metodrådet SLL-Gotland
Claes Lennmarken
Docent, medicinsk rådgivare
[email protected]
Elisabeth Persson
Docent, medicinsk rådgivare
[email protected]
3 (3)
Utvidgad referenslista
1. Atas A, Tutar H, Gunduz B, Bayazit YA. Vibrant sound bridge application to middle ear windows
versus conventional hearing aids: a comparative study based on international outcome inventory for
hearing aids. European archives of oto-rhino-laryngology: official journal of the European
Federation of Oto-Rhino-Laryngological Societies (EUFOS): affiliated with the German Society for
Oto-Rhino-Laryngology - Head and Neck Surgery. 2014;271(1):35-40.
2. Barbara M, Biagini M, Monini S. The totally implantable middle ear device ’Esteem’ for
rehabilitation of severe sensorineural hearing loss. Acta Otolaryngol. 2011;131(4):399-404.
3. Bassim MK, Fayad JN. Implantable middle ear hearing devices: A review. Seminars in Hearing.
2010;31(1):28-36.
4. Baumgartner WD, Boheim K, Hagen R, Muller J, Lenarz T, Reiss S, et al. The vibrant soundbridge
for conductive and mixed hearing losses: European multicenter study results. Adv Otorhinolaryngol.
2010;69:38-50.
5. Bernardeschi D, Hoffman C, Benchaa T, Labassi S, Beliaeff M, Sterkers O, et al. Functional results
of Vibrant Soundbridge middle ear implants in conductive and mixed hearing losses. Audiol
Neurootol. 2011;16(6):381-7.
6. Boeheim K, Pok SM, Schloegel M, Filzmoser P. Active middle ear implant compared with open-fit
hearing aid in sloping high-frequency sensorineural hearing loss. Otol Neurotol. 2010;31(3):424-9.
7. Boheim K, Mlynski R, Lenarz T, Schlogel M, Hagen R. Round window vibroplasty: long-term
results. Acta Otolaryngol. 2012;132(10):1042-8.
8. Butler CL, Thavaneswaran P, Lee IH. Efficacy of the active middle-ear implant in patients with
sensorineural hearing loss. The Journal of laryngology and otology. 2013;127 Suppl 2:S8-16.
9. Claros P, Pujol Mdel C. Active middle ear implants: Vibroplasty in children and adolescents with
acquired or congenital middle ear disorders. Acta Otolaryngol. 2013;133(6):612-9.
10. Colletti L, Mandala M, Colletti V. Long-term outcome of round window Vibrant SoundBridge
implantation in extensive ossicular chain defects. Otolaryngology—head and neck surgery : official
journal of American Academy of Otolaryngology-Head and Neck Surgery. 2013;149(1):134-41.
11. de Abajo J, Sanhueza I, Giron L, Manrique M. Experience with the active middle ear implant in
patients with moderate-to-severe mixed hearing loss: indications and results. Otol Neurotol.
2013;34(8):1373-9.
12. Dillon MT, Tubbs RS, Adunka MC, King ER, Hillman TA, Adunka OF, et al. Round Window
Stimulation for Conductive and Mixed Hearing Loss. Otol Neurotol. 2014;35(9):1601-8.
13. Edfeldt L, Rask-Andersen H. Round window vibroplasty in chronic ear surgery: comparison with
conventional hearing rehabilitation. Acta Otolaryngol. 2013;133(8):814-25.
14. Edfeldt L, Stromback K, Grendin J, Bunne M, Harder H, Peebo M, et al. Evaluation of cost-utility in
middle ear implantation in the ’Nordic School’: a multicenter study in Sweden and Norway. Acta
Otolaryngol. 2014;134(1):19-25.
15. Gunduz B, Atas A, Bayazit YA, Goksu N, Gokdogan C, Tutar H. Functional outcomes of Vibrant
Soundbridge applied on the middle ear windows in comparison with conventional hearing aids. Acta
Otolaryngol. 2012;132(12):1306-10.
16. Henseler MA, Polanski JF, Schlegel C, Linder T. Active middle ear implants in patients undergoing
subtotal petrosectomy: long-term follow-up. Otol Neurotol. 2014;35(3):437-41.
17. Huttenbrink KB, Beutner D, Zahnert T. Clinical results with an active middle ear implant in the oval
window. Adv Otorhinolaryngol. 2010;69:27-31.
18. Ihler F, Bewarder J, Blum J, Matthias C, Canis M. Long-term functional outcome and satisfaction of
patients with an active middle ear implant for sensorineural hearing loss compared to a matched
population with conventional hearing aids. European archives of oto-rhino-laryngology : official
journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated
with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2013.
4 (4)
19. Ihler F, Kohler S, Meyer AC, Blum J, Strenzke N, Matthias C, et al. Mastoid cavity obliteration and
Vibrant Soundbridge implantation for patients with mixed hearing loss. Laryngoscope.
2014;124(2):531-7.
20. Kahue CN, Carlson ML, Daugherty JA, Haynes DS, Glasscock ME, 3rd. Middle ear implants for
rehabilitation of sensorineural hearing loss: a systematic review of FDA approved devices. Otol
Neurotol. 2014;35(7):1228-37.
21. Klein K, Nardelli A, Stafinski T. A systematic review of the safety and effectiveness of fully
implantable middle ear hearing devices: the carina and esteem systems. Otol Neurotol.
2012;33(6):91622. Lesinskas E, Stankeviciute V, Petrulionis M. Application of the Vibrant Soundbridge middle-ear
implant for aural atresia in patients with Treacher Collins syndrome. The Journal of laryngology and
otology. 2012;126(12):1216-23.
23. Lim LH, Del Prado J, Xiang L, Yusof AR, Loo JH. Vibrant Soundbridge middle ear implantations:
experience at National University Hospital Singapore. European archives of oto-rhino-laryngology :
official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) :
affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery.
2012;269(9):2137-43.
24. Luers JC, Huttenbrink KB, Zahnert T, Bornitz M, Beutner D. Vibroplasty for mixed and conductive
hearing loss. Otol Neurotol. 2013;34(6):1005-12.
25. Mandala M, Colletti L, Colletti V. Treatment of the atretic ear with round window vibrant
soundbridge implantation in infants and children: electrocochleography and audiologic outcomes.
Otol Neurotol. 2011;32(8):1250-5.
26. Marino R, Linton N, Eikelboom RH, Statham E, Rajan GP. A comparative study of hearing aids and
round window application of the vibrant sound bridge (VSB) for patients with mixed or conductive
hearing loss. Int J Audiol. 2013;52(4):209-18.
27. McKinnon BJ, Dumon T, Hagen R, Lesinskas E, Mlynski R, Profant M, et al. Vibrant soundbridge
in aural atresia: does severity matter? European archives of oto-rhino-laryngology : official journal
of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the
German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2014;271(7):1917-21.
28. Memari F, Asghari A, Daneshi A, Jalali A. Safety and patient selection of totally implantable
hearing aid surgery: Envoy system, Esteem. European archives of oto-rhino-laryngology : official
journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated
with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery. 2011;268(10):14215.
29. Monini S, Biagini M, Atturo F, Barbara M. Esteem® middle ear device versus conventional hearing
aids for rehabilitation of bilateral sensorineural hearing loss. European archives of oto-rhinolaryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies
(EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck
Surgery. 2013;270(7):2027-33.
30. Pok SM, Schlogel M, Boheim K. Clinical experience with the active middle ear implant Vibrant
Soundbridge in sensorineural hearing loss. Adv Otorhinolaryngol. 2010;69:51-8.
31. Rameh C, Meller R, Lavieille JP, Deveze A, Magnan J. Long-Term Patient Satisfaction With
Different Middle Ear Hearing Implants in Sensorineural Hearing Loss. Otology & Neurotology.
2010;31(6):883-92.
32. Roman S, Denoyelle F, Farinetti A, Garabedian EN, Triglia JM. Middle ear implant in conductive
and mixed congenital hearing loss in children. Int J Pediatr Otorhinolaryngol. 2012;76(12):1775-8.
33. Schwab B, Salcher RB, Maier H, Kontorinis G. Oval window membrane vibroplasty for direct
acoustic cochlear stimulation: treating severe mixed hearing loss in challenging middle ears. Otol
Neurotol. 2012;33(5):804-9.
34. Shohet JA, Kraus EM, Catalano PJ. Profound high-frequency sensorineural hearing loss treatment
with a totally implantable hearing system. Otol Neurotol. 2011;32(9):1428-31.
35. Snik A, Verhaegen V, Mulder J, Cremers C. Cost-effectiveness of implantable middle ear hearing
devices. Adv Otorhinolaryngol. 2010;69:14-9.
5 (5)
36. Sziklai I, Szilvassy J. Functional gain and speech understanding obtained by Vibrant Soundbridge or
by open-fit hearing aid. Acta Otolaryngol. 2011;131(4):428-33.
37. Tysome JR, Moorthy R, Lee A, Jiang D, O’Connor AF. Systematic review of middle ear implants:
do they improve hearing as much as conventional hearing AIDS? Otol Neurotol. 2010;31(9):136975.
38. Verhaegen VJ, Mulder JJ, Cremers CW, Snik AF. Application of active middle ear implants in
patients with severe mixed hearing loss. Otol Neurotol. 2012;33(3):297-301.
39. Verhaert N, Desloovere C, Wouters J. Acoustic hearing implants for mixed hearing loss: a
systematic review. Otol Neurotol. 2013;34(7):1201-9.
40. Verhaert N, Fuchsmann C, Tringali S, Lina-Granade G, Truy E. Strategies of active middle ear
implants for hearing rehabilitation in congenital aural atresia. Otol Neurotol. 2011;32(4):639-45.
41. Verhaert N, Mojallal H, Schwab B. Indications and outcome of subtotal petrosectomy for active
middle ear implants. European archives of oto-rhino-laryngology : official journal of the European
Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for
Oto-Rhino-Laryngology - Head and Neck Surgery. 2013;270(4):1243-8.
42. Wolf-Magele A, Schnabl J, Woellner T, Koci V, Riechelmann H, Sprinzl GM. Active middle ear
implantation in elderly people: a retrospective study. Otol Neurotol. 2011;32(5):805-11.
43. Yu JK, Tsang WS, Wong TK, Tong MC. Outcome of vibrant soundbridge middle ear implant in
cantonese-speaking mixed hearing loss adults. Clin Exp Otorhinolaryngol. 2012;5 Suppl 1:S82-8.
44. Zernotti ME, Arauz SL, Di Gregorio MF, Arauz SA, Tabernero P, Romero MC. Vibrant
Soundbridge in congenital osseous atresia: multicenter study of 12 patients with osseous atresia.
Acta Otolaryngol. 2013;133(6):569-73.
45. Zernotti ME, Gregorio MF, Sarasty AC. Middle ear implants: functional gain in mixed hearing loss.
Braz J Otorhinolaryngol. 2012;78(1):109-12.
46. Zwartenkot JW, Hashemi J, Cremers CW, Mulder JJ, Snik AF. Active middle ear implantation for
patients with sensorineural hearing loss and external otitis: long-term outcome in patient
satisfaction. Otol Neurotol. 2013;34(5):855-61.
47. Zwartenkot JW, Mulder JJ, Snik AF, Cremers CW. Vibrant Soundbridge surgery in patients with
severe external otitis: complications of a transcanal approach. Otol Neurotol. 2011;32(3):398-402.

Download Report