**3. Results**

Eighty-two surgeries were performed in total, being 46 as primary intervention, 6 explantation, 4 revisions, and 27 battery changes. In three of the 46 primary surgeries, the procedure was interrupted due to low motility of the ossicular chain as shown by LDV in two cases and insufficient mastoid space in one case. So, the overall number of implants was 43. Implantation was always performed unilaterally, in the worse functioning ear of bilaterally hearing-impaired subjects; one subject was implanted while presenting with a unilateral severe SNHL. Bilateral application was completed in two subjects. Revision surgery was needed in three subjects for a developed fibrous tissue formation that impeded the normal movement of the ossicular chain and the transducers.

The outcome from Esteem® implantation has been analyzed taking into account several aspects, going from (a) the auditory improvement, (b) the comparison with the efficacy of a conventional hearing aid, (c) the patient's quality of life, and (d) the complication rate and the solutions for resolving these latter.

#### **4. Auditory improvement**

The mean postoperative pure tone threshold measured between 250 and 4000 Hz revealed an improvement of 5–10 dB in 9 subjects, 11–20 dB in 17 cases, 21–30 dB in 5 cases, and more than 30 dB in 3 cases. A −10/−20-dB deterioration was found in two subjects, and a −5/−10-dB deterioration was found in three subjects. Overall, more than 80% of the implanted subjects showed an improvement in respect to the preoperative unaided bone conduction thresholds. More specifically,

**97**

**5. Discussion**

*The Esteem®, Fully Implantable Middle Ear Device DOI: http://dx.doi.org/10.5772/intechopen.89250*

8 kHz, it was detected in 35% of them.

Bonebridge® (Medel, Innsbruck, Austria).

object of a previous publication [8].

**4.1 Esteem vs. hearing aids**

**4.2 Quality of life**

**4.3 Complications**

an improved threshold at 4 kHz was measured in 62.5% of the implantees, while at

The data relative to the efficacy of the Esteem® AMEI in comparison with the hearing aids has already been object of a previous publication [5]. In that report, two groups of subjects were identified: the first one with a moderate-to-severe SNHL and the other one with severe-to-profound SNHL, being theoretically beyond the indication range limit recommended by the manufacturer (off-label). In moderateto-severe cases, no statistical differences with the hearing aids were shown in the speech-in-noise tests, while subjectively, the implanted subjects reported a higher level of satisfaction in terms of a better quality of life. In the severe-to-profound subjects, similar results were obtained so as to also consider this range of hearing loss, a plausible threshold for implantation, as also outlined by other investigators [6]. The mean gain difference in favor of the Esteem® versus a cHA was equal to

13.1 dB, thus very similar to what previously reported by Kraus et al. [6].

The data relative to the quality of life issue has already been reported [7]. This group of patients has been pooled together with other subjects receiving different types of auditory implant. In total, this survey has taken into consideration the 26 Esteem® subjects who were all asked to fill different questionnaires including the General Glasgow Benefit Inventory, the visual analogue scale (VAS), and the abbreviated profile of hearing aid benefit (APHAB). The improvement of quality of sound was similar to the other implanted devices, whilst the score for quality of life was superior to both percutaneous bone conductive implants and to the Vibrant Soundbridge® (Medel, Innsbruck, Austria), equaling only that measured with the

It is important to distinguish two typologies of complications: one related to the surgical procedure, being inescapably part of it, and the other one as true complications. The surgical procedure implies the disconnection between incus and stapes so that an additional conductive component to the subject's hearing loss is always postoperatively evident. The other aspect regards the need for sacrificing the chorda tympani nerve so that a taste disturbance could be the consequence of it. In this regard, however, only a very limited number of subjects reported a permanent dysgeusia. Finally, it has also to be considered that the need to reconstruct the ossicular chain should an explantation be needed. Among the true complications, the need for explantation occurred in six subjects: for skin dehiscence (one subject), loud noise (one subject), tinnitus (one subject), and hearing threshold deterioration (three subjects). Four subjects required a surgical revision and in about 9% of the cases, a delayed transient facial palsy was observed, with remarks that were

The Esteem® fully implantable AMEI represents a real alternative to conventional hearing aids when this latter one show to be inappropriate or unable an improved threshold at 4 kHz was measured in 62.5% of the implantees, while at 8 kHz, it was detected in 35% of them.
