Table I.
Consensus statements with results in voting rounds 1, 2 and 3.
| Consensus statements | Voting round 1 | Voting round 2 | Voting round 3 |
|---|---|---|---|
| Pre-operative tests | |||
| Statement 1. Audiological tests, imaging and questionnaires are necessary for the pre-operative evaluation in candidates for surgery. | Consensus statement reached ≥ 70% agreement (75%) | ||
| Statement 2. Audiological tests with soft band are useful only for BCDs candidates and not for AMEI candidates. | Consensus statement reached < 70% agreement (60%). Round 2 was necessary | Consensus statement reached < 70% agreement (69%). Round 3 was necessary | Consensus statement reached ≥ 70% agreement (75%) |
| Otological indications | |||
| Statement 3. For the treatment of chronic otitis media, implantation of BCDs is recommended only after failure of other surgical treatments. | Consensus statement reached < 70% agreement (60%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (86%) | |
| Statement 4. Implantation of an AMEI (VSB) is recommended only after years of recovery from chronic otitis media (dry ear, imaging of the middle ear free from cholesteatoma). | Consensus statement reached < 70% agreement (57.1%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (86%) | |
| Statement 5. Percutaneous BCDs are useful for the treatment of CHL/MHL due to otosclerosis. These devices are recommended only in cases of surgical failure, or in cases in which a surgical revision exposes the patient to a high risk of deafness and CHAs cannot be fitted. | Consensus statement reached < 70% agreement (50%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (80%) | |
| Statement 6. AMEIs are useful for the treatment of severe/profound MHL due to otosclerosis, placed during or after stapes surgery. | Consensus statement reached < 70% agreement (46.1%). Round 2 was necessary | Consensus statement reached < 70% agreement (64%). Round 3 was necessary | Consensus statement reached ≥ 70% agreement (73%) |
| Statement 7. CHL in children, especially if bilateral and greater than 35 dBHL, should be treated surgically (e.g., by placement of ventilation tubes) or by CHAs in order to treat the hearing impairment that adds to the patient’s cognitive disabilities. | Consensus statement reached ≥ 70% agreement (71.4%) | ||
| Audiological indications | |||
| Statement 8. BCDs are a second treatment option after CROS system or CI for the treatment of the SSD. | Consensus statement reached < 70% agreement (57.1%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (93%) | |
| Statement 9. In SSD the percutaneous BCD should be used in order to optimise sound conduction and to reduce retroauricular incision that can lead to problems for a future CI positioning. | Consensus statement reached < 70% agreement (50%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (79%) | |
| Statement 10. CHAs are the best choice for asymmetric SNHL when CIs are not indicated. | Consensus statement reached < 70% agreement (50%). Round 2 was necessary | Consensus statement reached < 70% agreement (60%). Round 3 was necessary | Consensus statement reached ≥ 70% agreement (80%) |
| Statement 11. In asymmetric hearing loss, if you decide to use a bone conduction device, percutaneous BCDs should be used in order to optimise the sound conduction and to reduce retroauricular incision that can lead to problems in future CI positioning. | Consensus statement reached < 70% agreement (42.8%). Round 2 was necessary | Consensus statement reached < 70% agreement (53%). Round 3 was necessary | Consensus statement reached ≥ 70% agreement (80%) |
| Statement 12. In case of CI treating a severe hearing loss, and contralateral moderate-to-severe hearing loss without the possibility of fitting a conventional hearing aid, the best choice is a bimodal stimulation with CI in the worse ear and an AMEI or BCD in the better ear. | Consensus statement reached < 70% agreement (66.7%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (93%) | |
| Statement 13. BCDs are indicated in children affected by a permanent unilateral CHL/MHL because without the rehabilitation of the weak ear, the neurologic pathway of binaural hearing does not develop, and the child will never be able to reach the binaural advantages such as localisation and speech in noise. | Consensus statement reached < 70% agreement (46.1%). Round 2 was necessary | Consensus statement reached < 70% agreement (67%). Round 3 was necessary | Consensus statement reached ≥ 70% agreement (73%) |
| Statement 14. AMEIs are indicated in children affected by a permanent unilateral CHL/MHL because without the rehabilitation of the weak ear, the neurologic pathway of binaural hearing does not develop, and the child will never be able to reach the binaural advantages such as localisation and speech in noise. | Consensus statement reached < 70% agreement (50%). Round 2 was necessary | Consensus statement reached < 70% agreement (60%). Round 3 was necessary | Consensus statement reached ≥ 70% agreement (80%) |
| Statement 15. In adults affected by unilateral CHL/MHL, BCDs are not able to restore the binaural hearing due to reduction in transcranial attenuation. | Consensus statement reached < 70% agreement (46.7%). Round 2 was necessary | Consensus statement reached < 70% agreement (60%). Round 3 was necessary | Consensus statement reached ≥ 70% agreement (80%) |
| Statement 16. In adults affected by unilateral CHL/MHL, AMEIs are indicated because thanks to the selective stimulation of the deaf ear they allow retention of the binaural cues. | Consensus statement reached < 70% agreement (42.8%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (71%) | |
| Statement 17. In cases where implantable hearing devices are indicated, binaural fitting is strongly recommended for both AMEIs and BCDs to treat permanent symmetric bilateral CHL or MHL in children. | Consensus statement reached < 70% agreement (53.8%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (93%) | |
| Statement 18. In cases where implantable hearing devices are indicated, binaural fitting is strongly recommended for both AMEIs and BCDs to treat symmetric bilateral CHL or MHL in adults. | Consensus statement reached < 70% agreement (50%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (93%) | |
| Statement 19. Implantable devices are indicated in patients with temporary stabilisation of progression of hearing loss when audiological/radiological features allow the correct fitting. | Consensus statement reached < 70% agreement (53.3%). Round 2 was necessary | Consensus statement reached < 70% agreement (67%). Round 3 was necessary | Consensus statement reached ≥ 70% agreement (80%) |
| Statement 20. Auditory deprivation could negatively influence binaural cue rehabilitation, but it is not a contraindication for the implantable devices. | Consensus statement reached < 70% agreement (66.7%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (86%) | |
| Surgical indications | |||
| Statement 21. Age limits on placing an implantable device are related to the kind of anaesthesia (local or general anaesthesia) and to the anatomical contraindications (e.g., thickness of the skull) but not to the devices. | Consensus statement reached < 70% agreement (50%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (93%) | |
| Statement 22. Surgical procedures for percutaneous BCDs may be performed under local anaesthesia in adults. | Consensus statement reached < 70% agreement (60%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (86%) | |
| Statement 23. Surgical procedure for percutaneous BCDs must be performed in an operating theatre. | Consensus statement reached < 70% agreement (50%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (73%) | |
| Statement 24. Surgical procedure for transcutaneous BCDs may be performed under local anaesthesia with sedation in adults. | Consensus statement reached < 70% agreement (50%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (73%) | |
| Statement 25. Surgical procedure for transcutaneous BCDs must be performed in an operating theatre. | Consensus statement reached ≥ 70% agreement (76.9%) | ||
| Statement 26. Surgical procedure for AMEIs must be performed under general anaesthesia. | Consensus statement reached < 70% agreement (41.7%). Round 2 was necessary | Consensus statement reached ≥ 70% agreement (78%) | |
| Statement 27. Surgical procedure for AMEIs must be performed in an operating theatre. | Consensus statement reached ≥ 70% agreement (84.6%) | ||
| Statement 28. In case of concomitant need for reconstruction of the auricle, the implant should be placed in a more postero-superior location than normal so as not to injure the skin flap and compromise subsequent reconstruction of the auricle/placement of the epithesis. | Consensus statement reached ≥ 70% agreement (92.3%) | ||
| Statement 29. In case of malformities of the middle ear, it is recommended to perform middle ear surgery by reconstructive procedures on the ossicular chain with CHAs if socially useful hearing is not achieved. | Consensus statement reached ≥ 70% agreement (71.4%) | ||
| AMEI(s): active middle ear implant(s); BCD(s): bone conduction device(s); CROS: contralateral routing of signals; CHAs: conventional hearing aids; CHL: conductive hearing loss; CI(s): cochlear implant(s); MHL: mixed hearing loss; SNHL: sensorineural hearing loss; SSD: single-sided deafness; VSB: vibrant soundbridge. | |||