**4.1 Esteem vs. hearing aids**

*Advances in Rehabilitation of Hearing Loss*

15.The SP is then put in place and attached to the sensor and driver cables. Final LDV measurements of the whole system are then carried out and precede the

*Normative data regarding displacement of the incus (left) and stapes (right) when measured by laser Doppler* 

A bandage is then wrapped around the head and kept for 24 h. The implant is activated approximately 2 months after surgery, with the first fitting session, and

Once required, the SP will be substituted via a minor surgical procedure, oftentimes performed under local anesthesia. The procedure entails a C-shaped, 5-cm long skin incision behind the SP that is subsequently exposed to allow first the disconnection from the cables of the two transducers, then their reconnection to the new SP.

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

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 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,

end of surgery with a three-layer closure.

later upgraded every 3 months during the first postoperative year.

the complication rate and the solutions for resolving these latter.

**96**

**3. Results**

**Figure 4.**

*vibrometry.*

ossicular chain and the transducers.

**4. Auditory improvement**

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].
