Abstract
A fully implantable active middle ear device has been proposed and indicated for the rehabilitation of bilateral moderate or moderate-to-severe sensorineural hearing loss, assuming it would overcome the disadvantages of a conventional hearing aid. The indications have further been extended to severe or severe-to-profound forms of hearing loss in the case of an expected limited or null efficacy of hearing aids. While the literature has highlighted several positive aspects of the device, including a better quality of life related to its invisibility, the improvement of auditory and perceptual functions has not been controlled for throughout a long period of follow-up. The present study aimed to verify the behavior of the auditory threshold, especially the bone conduction (BC) component, in the implanted ear in a group of implantees affected by initial bilateral symmetric hearing loss of different severity grades. The BC threshold was assessed preoperatively at activation and at the last follow-up (ranging from 4 to 12 years) in the implanted ear, and preoperatively and at the last follow-up in the contralateral ear, to monitor eventual deteriorated values in both ears over time. The pure tone average (PTA; 250–4,000 Hz), speech reception threshold (SRT) and the maximum word recognition score as a percentage (% WRS) and in dB HL were measured in the implanted ear to verify the efficacy of the device after the first fitting at device activation. A significant worsening of the BC threshold with respect to the baseline threshold was noticed during further follow-up. When comparing the implanted ear with the contralateral ear, a significant worsening of the bone PTA was assessed in the former with respect to the contralateral ear. Despite the worsened hearing found in the implanted ears, the beneficial gains in PTA and speech audiometry observed at the first activation remained constant at the follow-up, thus showing an extension of the efficacy of this device in aiding those with up to the most severe forms of sensorineural hearing loss.
Highlights
Active middle ear implants (AMEIs), either semi- or fully implantable, have been proposed as an alternative to conventional hearing aids (CHA) in subjects with moderate-to-severe hearing loss (HL) to overcome some of the issues observed with CHA, such as limited high-frequency amplification and incompatibility with a chronic inflammatory condition of the external auditoryHearing Progression in an AMEI canal [1]
The unaided threshold was assessed at the time of activation to quantify the degree of conductive loss that was due to ossicular chain interruption as well as the level of the bone conduction (BC) threshold
Out of the 43 subjects who received the fully implantable AMEI (FI-AMEI) at our tertiary care center, 9 were lost to follow-up; 1 patient was explanted after 6 years of continuous use for other medical problems and 2 patients had the implant removed due to post-operative complications
Summary
Active middle ear implants (AMEIs), either semi- or fully implantable, have been proposed as an alternative to conventional hearing aids (CHA) in subjects with moderate-to-severe hearing loss (HL) to overcome some of the issues observed with CHA, such as limited high-frequency amplification and incompatibility with a chronic inflammatory condition of the external auditoryHearing Progression in an AMEI canal [1]. Active middle ear implants (AMEIs), either semi- or fully implantable, have been proposed as an alternative to conventional hearing aids (CHA) in subjects with moderate-to-severe hearing loss (HL) to overcome some of the issues observed with CHA, such as limited high-frequency amplification and incompatibility with a chronic inflammatory condition of the external auditory. One fully implantable AMEI (FI-AMEI) has been proposed for subjects with a greater degree of sensorineural hearing loss (SNHL), such as the severe or severe-to-profound type for which CHA would be undoubtedly inadequate [2,3,4] In this regard, an 11–13 dB difference was reported when comparing the hearing performances of the same subject using the FIAMEI with that of using a last generation CHA [5], a difference theoretically related to the FI-AMEI’s better high-frequency amplification. Should the occurrence of eventual postoperative complications (middle ear fibrous growth or device failure, for example) prompt a device’s explantation, ossicular reconstruction will become necessary
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